Data as of 2026-07-12 — 788,886 rows loaded

007337

NDA ENDO OPERATIONS
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
005 PERCODAN-DEMI ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued
006 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued
007 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AA ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 59 AP 2026-06-18 REMS N/A
SUPPL 58 AP 2025-12-22 LABELING STANDARD
SUPPL 57 AP 2024-11-21 LABELING STANDARD
SUPPL 56 AP 2024-10-31 REMS N/A
SUPPL 55 AP 2024-04-19 LABELING STANDARD
SUPPL 54 AP 2023-12-15 LABELING STANDARD
SUPPL 53 AP 2021-04-28 LABELING STANDARD
SUPPL 52 AP 2019-10-07 LABELING STANDARD
SUPPL 51 AP 2018-09-18 LABELING STANDARD
SUPPL 50 AP 2018-09-18 REMS N/A
SUPPL 49 AP 2016-12-16 LABELING STANDARD
SUPPL 48 AP 2014-01-21 MANUF (CMC) STANDARD
SUPPL 47 AP 2013-09-24 MANUF (CMC) STANDARD
SUPPL 46 AP 2010-07-28 LABELING UNKNOWN
SUPPL 45 AP 2010-03-11 LABELING UNKNOWN
SUPPL 43 AP 2006-08-11 MANUF (CMC) STANDARD
SUPPL 29 AP 2004-06-10 LABELING STANDARD
SUPPL 30 AP 2002-04-29 MANUF (CMC) STANDARD
SUPPL 27 AP 1995-03-17 MANUF (CMC) STANDARD
SUPPL 23 AP 1994-04-20 MANUF (CMC) STANDARD
SUPPL 25 AP 1994-04-19 MANUF (CMC) STANDARD
SUPPL 24 AP 1989-06-14 LABELING
SUPPL 22 AP 1987-12-17 MANUF (CMC) STANDARD
SUPPL 20 AP 1986-07-10 LABELING
SUPPL 18 AP 1983-11-03 MANUF (CMC) STANDARD
SUPPL 16 AP 1982-03-04 MANUF (CMC) STANDARD
SUPPL 14 AP 1980-01-24 MANUF (CMC) STANDARD
SUPPL 12 AP 1976-01-28 MANUF (CMC) STANDARD
SUPPL 11 AP 1975-07-28 LABELING
SUPPL 10 AP 1975-03-31 MANUF (CMC) STANDARD
SUPPL 9 AP 1975-03-31 MANUF (CMC) STANDARD
ORIG 1 AP 1950-04-12 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2026-06-23 Letter SUPPL-59 0
2026-01-06 Label SUPPL-58 0
2026-01-06 Medication Guide SUPPL-58 0
2025-12-29 Letter SUPPL-58 0
2024-11-25 Letter SUPPL-57 0
2024-11-22 Label SUPPL-57 0
2024-11-04 Letter SUPPL-56 0
2024-04-23 Label SUPPL-55 0
2024-04-22 Letter SUPPL-55 0
2023-12-18 Label SUPPL-54 0
2023-11-03 REMS ORIG-1 0
2021-04-29 Letter SUPPL-53 0
2021-04-29 Label SUPPL-53 0
2019-10-08 Label SUPPL-52 0
2019-10-08 Letter SUPPL-52 0
2018-10-05 Label SUPPL-50 0
2018-10-05 Label SUPPL-51 0
2018-09-28 Letter SUPPL-50 0
2018-09-28 Letter SUPPL-51 0
2016-12-21 Label SUPPL-49 0
2016-12-19 Letter SUPPL-49 0
2010-07-31 Label SUPPL-46 0
2010-07-30 Letter SUPPL-46 0
2010-03-18 Letter SUPPL-45 0
2010-03-18 Label SUPPL-45 0
2006-08-21 Letter SUPPL-43 0
2006-08-14 Label SUPPL-43 0
2004-06-15 Letter SUPPL-29 0
2004-06-15 Label SUPPL-29 0
2003-08-08 Review SUPPL-24 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "51", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "55", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "54", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "52", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "50", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "46", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "57", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "54", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "58", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "52", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "59", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "56", "ActionTypes_LookupID": "55"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "59", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "58", "SubmissionPropertyTypeCode": "Null"}
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2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "54", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "53", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "52", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "51", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "50", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "49", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "46", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "45", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
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2026-07-12 te INSERT {"ApplNo": "007337", "ProductNo": "007", "TECode": "AA"}
2026-07-12 marketing_status INSERT {"ApplNo": "007337", "ProductNo": "007"}
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2026-07-12 marketing_status INSERT {"ApplNo": "007337", "ProductNo": "005"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
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2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
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2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "46"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "49"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "50"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "51"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "52"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "53"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "54"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "55"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "56"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "57"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "58"}
2026-07-12 submissions INSERT {"ApplNo": "007337", "SubmissionType": "SUPPL", "SubmissionNo": "59"}
2026-07-12 products INSERT {"ApplNo": "007337", "ProductNo": "007"}
2026-07-12 products INSERT {"ApplNo": "007337", "ProductNo": "006"}
2026-07-12 products INSERT {"ApplNo": "007337", "ProductNo": "005"}
2026-07-12 applications INSERT {"ApplNo": "007337"}