Data as of 2026-07-13 — 788,886 rows loaded

017029

NDA FRESENIUS KABI USA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription AP ✓ ✓
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued
003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription AP ✓ ✓
004 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML Prescription AP ✓ ✓
010 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription AP ✓ ✓
013 HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription AP ✓ ✓
014 HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription AP ✓ ✓
015 HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription AP ✓ ✓
016 HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML Prescription AP ✓ ✓
019 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription AP ✓ ✓
020 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML Prescription ✓ ✓
021 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM INJECTABLE;INJECTION 40 UNITS/ML Discontinued ✓
022 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM INJECTABLE;INJECTION 50 UNITS/ML Prescription ✓ ✓
023 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% HEPARIN SODIUM INJECTABLE;INJECTION 100 UNITS/ML Prescription ✓ ✓
024 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM INJECTABLE;INJECTION 50 UNITS/ML Prescription ✓ ✓
025 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM INJECTABLE;INJECTION 100 UNITS/ML Prescription ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 178 AP 2024-10-24 LABELING STANDARD
SUPPL 159 AP 2021-06-07 LABELING STANDARD
SUPPL 156 AP 2020-07-02 LABELING STANDARD
SUPPL 141 AP 2018-11-16 LABELING STANDARD
SUPPL 140 AP 2017-08-24 LABELING STANDARD
SUPPL 139 AP 2016-06-09 MANUF (CMC) STANDARD
SUPPL 129 AP 2015-12-23 MANUF (CMC) STANDARD
SUPPL 137 AP 2015-07-21 MANUF (CMC) STANDARD
SUPPL 134 AP 2015-03-09 MANUF (CMC) STANDARD
SUPPL 135 AP 2014-03-21 LABELING UNKNOWN
SUPPL 136 AP 2013-09-24 MANUF (CMC) STANDARD
SUPPL 131 AP 2011-12-23 LABELING UNKNOWN
SUPPL 128 AP 2011-06-24 LABELING UNKNOWN
SUPPL 115 AP 2011-03-31 MANUF (CMC) N/A
SUPPL 120 AP 2010-06-11 LABELING UNKNOWN
SUPPL 108 AP 2008-09-23 LABELING STANDARD
SUPPL 99 AP 2002-03-22 LABELING STANDARD
SUPPL 97 AP 2000-03-08 MANUF (CMC) STANDARD
SUPPL 98 AP 1999-12-13 MANUF (CMC) STANDARD
SUPPL 62 AP 1998-08-06 MANUF (CMC) STANDARD
SUPPL 63 AP 1998-08-06 MANUF (CMC) STANDARD
SUPPL 94 AP 1998-08-06 MANUF (CMC) STANDARD
SUPPL 96 AP 1997-11-04 MANUF (CMC) STANDARD
SUPPL 95 AP 1997-06-24 MANUF (CMC) STANDARD
SUPPL 73 AP 1996-07-26 MANUF (CMC) STANDARD
SUPPL 84 AP 1995-05-17 MANUF (CMC) STANDARD
SUPPL 78 AP 1994-10-27 MANUF (CMC) STANDARD
SUPPL 69 AP 1993-08-25 LABELING
SUPPL 56 AP 1992-06-26 LABELING
SUPPL 57 AP 1989-12-01 MANUF (CMC) STANDARD
SUPPL 61 AP 1989-06-08 MANUF (CMC) STANDARD
SUPPL 60 AP 1988-09-22 LABELING
SUPPL 58 AP 1988-02-16 MANUF (CMC) STANDARD
SUPPL 50 AP 1987-09-22 MANUF (CMC) STANDARD
SUPPL 51 AP 1987-09-22 MANUF (CMC) STANDARD
SUPPL 54 AP 1986-04-28 MANUF (CMC) STANDARD
SUPPL 53 AP 1986-04-07 LABELING
SUPPL 42 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 43 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 44 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 45 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 46 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 47 AP 1985-12-05 MANUF (CMC) STANDARD
SUPPL 49 AP 1985-07-29 EFFICACY
SUPPL 37 AP 1985-05-16 MANUF (CMC) STANDARD
SUPPL 48 AP 1984-11-06 MANUF (CMC) STANDARD
SUPPL 34 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 36 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 38 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 39 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 40 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 41 AP 1983-11-02 MANUF (CMC) STANDARD
SUPPL 33 AP 1983-01-04 MANUF (CMC) STANDARD
SUPPL 31 AP 1982-09-21 MANUF (CMC) STANDARD
SUPPL 32 AP 1982-09-21 MANUF (CMC) STANDARD
SUPPL 29 AP 1982-09-17 MANUF (CMC) STANDARD
SUPPL 30 AP 1982-05-06 LABELING
SUPPL 26 AP 1981-03-24 MANUF (CMC) STANDARD
SUPPL 27 AP 1981-02-24 LABELING
SUPPL 24 AP 1979-10-31 MANUF (CMC) STANDARD
SUPPL 25 AP 1979-10-31 MANUF (CMC) STANDARD
SUPPL 22 AP 1978-11-21 MANUF (CMC) STANDARD
SUPPL 23 AP 1978-11-21 MANUF (CMC) STANDARD
SUPPL 21 AP 1978-05-23 LABELING
SUPPL 20 AP 1977-12-14 MANUF (CMC) STANDARD
SUPPL 15 AP 1977-12-04 LABELING
SUPPL 16 AP 1977-01-26 MANUF (CMC) STANDARD
SUPPL 17 AP 1976-12-03 MANUF (CMC) STANDARD
SUPPL 19 AP 1976-12-03 MANUF (CMC) STANDARD
SUPPL 14 AP 1976-06-16 MANUF (CMC) STANDARD
SUPPL 9 AP 1976-03-17 MANUF (CMC) STANDARD
SUPPL 8 AP 1976-02-09 MANUF (CMC) STANDARD
SUPPL 12 AP 1976-02-09 LABELING
SUPPL 10 AP 1976-01-09 MANUF (CMC) STANDARD
SUPPL 11 AP 1976-01-09 MANUF (CMC) STANDARD
SUPPL 7 AP 1975-08-29 MANUF (CMC) STANDARD
ORIG 1 AP 1972-02-22 TYPE 5 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-10-28 Letter SUPPL-178 0
2024-10-25 Label SUPPL-178 0
2021-09-20 Label SUPPL-159 0
2021-06-08 Letter SUPPL-159 0
2020-07-06 Letter SUPPL-156 0
2020-07-06 Label SUPPL-156 0
2018-12-07 Letter SUPPL-141 0
2018-11-20 Label SUPPL-141 0
2017-08-28 Letter SUPPL-140 0
2017-08-28 Label SUPPL-140 0
2014-04-07 Letter SUPPL-135 0
2011-12-29 Letter SUPPL-131 0
2011-12-23 Label SUPPL-131 0
2011-07-05 Letter SUPPL-128 0
2010-06-24 Label SUPPL-120 0
2010-06-14 Letter SUPPL-120 0
2008-10-03 Label SUPPL-108 0
2008-09-26 Letter SUPPL-108 0
2002-03-22 Letter SUPPL-99 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "120", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "108", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "56", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "115", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "60", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "53", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "69", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "2"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "135", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "140", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "159", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "128", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "156", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "178", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "115", "ActionTypes_LookupID": "14"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "141", "ActionTypes_LookupID": "48"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "131", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "99", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "57", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "95", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "46", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "98", "ActionTypes_LookupID": "30"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "137", "ActionTypes_LookupID": "30"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "73", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "33"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "42"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "136", "ActionTypes_LookupID": "30"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "61", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "139", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "42"}
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2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "94", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "54", "ActionTypes_LookupID": "33"}
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2026-07-12 submission_property_type INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "178", "SubmissionPropertyTypeCode": "Null"}
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2026-07-12 submission_property_type INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "131", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "129", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "017029", "SubmissionType": "SUPPL", "SubmissionNo": "128", "SubmissionPropertyTypeCode": "Null"}
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