100 results for metformin
| ApplNo | Type | Drug Name | Active Ingredient | Form / Strength | Marketing Status | TE | Sponsor |
|---|---|---|---|---|---|---|---|
| 021842 | NDA | ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL — 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | TAKEDA PHARMS USA | |
| 021842 | NDA | ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL — 850MG;EQ 15MG BASE | Prescription | AB | TAKEDA PHARMS USA |
| 022024 | NDA | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 1GM;EQ 15MG BASE | Discontinued | TAKEDA PHARMS USA | |
| 022024 | NDA | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 1GM;EQ 30MG BASE | Discontinued | TAKEDA PHARMS USA | |
| 210212 | ANDA | ALOGLIPTIN AND METFORMIN HYDROCHLORIDE | ALOGLIPTIN AND METFORMIN HYDROCHLORIDE | TABLET; ORAL — 12.5MG/500MG | None (Tentative Approval) | MSN LABORATORIES PRIVATE LTD | |
| 210212 | ANDA | ALOGLIPTIN AND METFORMIN HYDROCHLORIDE | ALOGLIPTIN AND METFORMIN HYDROCHLORIDE | TABLET; ORAL — 12.5MG/1000MG | None (Tentative Approval) | MSN LABORATORIES PRIVATE LTD | |
| 210160 | ANDA | ALOGLIPTIN; METFORMIN HYDROCHLORIDE | ALOGLIPTIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — EQ 12.5MG BASE;500MG | None (Tentative Approval) | TORRENT PHARMS LTD | |
| 210160 | ANDA | ALOGLIPTIN; METFORMIN HYDROCHLORIDE | ALOGLIPTIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — EQ 12.5MG BASE;1GM | None (Tentative Approval) | TORRENT PHARMS LTD | |
| 021410 | NDA | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL — 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | SB PHARMCO | |
| 021410 | NDA | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL — 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | SB PHARMCO | |
| 021410 | NDA | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL — 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | SB PHARMCO | |
| 021410 | NDA | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL — 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | SB PHARMCO | |
| 021410 | NDA | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL — 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | SB PHARMCO | |
| 213900 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 50MG | None (Tentative Approval) | AUROBINDO PHARMA LIMITED | |
| 213900 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 150MG | None (Tentative Approval) | AUROBINDO PHARMA LIMITED | |
| 213900 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 500MG | None (Tentative Approval) | AUROBINDO PHARMA LIMITED | |
| 215255 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN | TABLET, EXTENDED RELEASE — 1000MG | None (Tentative Approval) | MACLEODS PHARMACEUTICALS LTD | |
| 215255 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN | TABLET, EXTENDED RELEASE — 50MG | None (Tentative Approval) | MACLEODS PHARMACEUTICALS LTD | |
| 215255 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN | TABLET, EXTENDED RELEASE — 150MG | None (Tentative Approval) | MACLEODS PHARMACEUTICALS LTD | |
| 215255 | ANDA | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN | TABLET, EXTENDED RELEASE — 500MG | None (Tentative Approval) | MACLEODS PHARMACEUTICALS LTD | |
| 210542 | ANDA | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 50MG;500MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 210542 | ANDA | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 50MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 210542 | ANDA | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 150MG;500MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 210542 | ANDA | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 150MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 218091 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN || METFORMIN | TABLET — 5MG | None (Tentative Approval) | SINOTHERAPEUTICS INC | |
| 218091 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN || METFORMIN | TABLET — 10MG | None (Tentative Approval) | SINOTHERAPEUTICS INC | |
| 218091 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN || METFORMIN | TABLET — 500MG | None (Tentative Approval) | SINOTHERAPEUTICS INC | |
| 218091 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN || METFORMIN | TABLET — 1000MG | None (Tentative Approval) | SINOTHERAPEUTICS INC | |
| 220642 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN, METFORMIN | TABLET, EXTENDED RELEASE — 2.5MG | None (Tentative Approval) | SCIEGEN PHARMACEUTICALS | |
| 220642 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN, METFORMIN | TABLET, EXTENDED RELEASE — 10MG | None (Tentative Approval) | SCIEGEN PHARMACEUTICALS | |
| 220642 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN, METFORMIN | TABLET, EXTENDED RELEASE — 5MG | None (Tentative Approval) | SCIEGEN PHARMACEUTICALS | |
| 220642 | ANDA | DAPAGLIFLOZIN AND METFORMIN | DAPAGLIFLOZIN, METFORMIN | TABLET, EXTENDED RELEASE — 500MG | None (Tentative Approval) | SCIEGEN PHARMACEUTICALS | |
| 211466 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | MICRO LABS |
| 211466 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | MICRO LABS |
| 211466 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | MICRO LABS |
| 211466 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | MICRO LABS |
| 211479 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | MSN |
| 211479 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | MSN |
| 211479 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | MSN |
| 211479 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | MSN |
| 211489 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | AUROBINDO PHARMA |
| 211489 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | AUROBINDO PHARMA |
| 211489 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | AUROBINDO PHARMA |
| 211489 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | AUROBINDO PHARMA |
| 211489 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET — 2.5MG | None (Tentative Approval) | AUROBINDO PHARMA | |
| 211491 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | SUN PHARM |
| 211491 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | SUN PHARM |
| 211491 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | SUN PHARM |
| 211536 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | CIPLA LTD |
| 211536 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | CIPLA LTD |
| 211536 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | CIPLA LTD |
| 211559 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | MACLEODS PHARMS |
| 211559 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | MACLEODS PHARMS |
| 211559 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | MACLEODS PHARMS |
| 211559 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | MACLEODS PHARMS |
| 211563 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | ALKEM LABS LTD |
| 211563 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | ALKEM LABS LTD |
| 211563 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | ALKEM LABS LTD |
| 211563 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | ALKEM LABS LTD |
| 211579 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | LUPIN |
| 211579 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | LUPIN |
| 211579 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | LUPIN |
| 211579 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | LUPIN |
| 211583 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 2.5MG;1GM | Prescription | AB | TEVA PHARMS USA INC |
| 211583 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;500MG | Prescription | AB | TEVA PHARMS USA INC |
| 211583 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | TEVA PHARMS USA INC |
| 211583 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;500MG | Prescription | AB | TEVA PHARMS USA INC |
| 211583 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;1GM | Prescription | AB | TEVA PHARMS USA INC |
| 211595 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1GM | Prescription | AB | CIPLA |
| 219755 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 10MG | None (Tentative Approval) | INVENTIA HEALTHCARE LIMITED | |
| 219755 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 5MG | None (Tentative Approval) | INVENTIA HEALTHCARE LIMITED | |
| 219755 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 500MG | None (Tentative Approval) | INVENTIA HEALTHCARE LIMITED | |
| 219755 | ANDA | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 2.5MG | None (Tentative Approval) | INVENTIA HEALTHCARE LIMITED | |
| 212198 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — 5MG;500MG | Discontinued | AB | ZYDUS PHARMS |
| 212198 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — 5MG;1GM | Discontinued | AB | ZYDUS PHARMS |
| 212198 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — 12.5MG;500MG | Discontinued | AB | ZYDUS PHARMS |
| 212198 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL — 12.5MG;1GM | Discontinued | AB | ZYDUS PHARMS |
| 212374 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET — 5MG/850MG | None (Tentative Approval) | AUROBINDO PHARMA LIMITED | |
| 212374 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET — 5MG/500MG | None (Tentative Approval) | AUROBINDO PHARMA LIMITED | |
| 220511 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 5MG/1000MG | None (Tentative Approval) | AJANTA PHARMA LTD | |
| 220511 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 10MG/1000MG | None (Tentative Approval) | AJANTA PHARMA LTD | |
| 220511 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 12.5MG/1000MG | None (Tentative Approval) | AJANTA PHARMA LTD | |
| 220511 | ANDA | EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE — 25MG/1000MG | None (Tentative Approval) | AJANTA PHARMA LTD | |
| 212362 | ANDA | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL — 5MG/1000MG | None (Tentative Approval) | MSN LABS PVT LTD | |
| 212362 | ANDA | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL — 10MG/1000MG | None (Tentative Approval) | MSN LABS PVT LTD | |
| 212362 | ANDA | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL — 12.5MG/1000MG | None (Tentative Approval) | MSN LABS PVT LTD | |
| 212362 | ANDA | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL — 25MG/1000MG | None (Tentative Approval) | MSN LABS PVT LTD | |
| 217049 | ANDA | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;2.5MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 217049 | ANDA | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG;5MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 217049 | ANDA | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 12.5MG;2.5MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 217049 | ANDA | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 25MG;5MG;1000MG | None (Tentative Approval) | ZYDUS PHARMS USA INC | |
| 212243 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG;1000MG | None (Tentative Approval) | CIPLA LTD | |
| 212373 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 5MG;500MG | None (Tentative Approval) | MACLEODS PHARMS LTD | |
| 212373 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 5MG;1000MG | None (Tentative Approval) | MACLEODS PHARMS LTD | |
| 212373 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 12.5MG;500MG | None (Tentative Approval) | MACLEODS PHARMS LTD | |
| 212373 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 12.5MG;1000MG | None (Tentative Approval) | MACLEODS PHARMS LTD | |
| 218483 | ANDA | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL — 12.5MG;1000MG | None (Tentative Approval) | PRINSTON PHARMA INC | |
| 213654 | ANDA | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 5MG; 1GM | None (Tentative Approval) | LUPIN LTD | |
| 213654 | ANDA | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 10MG; 1GM | None (Tentative Approval) | LUPIN LTD | |
| 213654 | ANDA | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL — 12.5MG; 1GM | None (Tentative Approval) | LUPIN LTD |