FDA.reportPublic FDA data

Application 077723

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL7.5MG;200MGNoNo
002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL10MG;200MGNoNo
003HYDROCODONEHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL5MG;200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar Pharmaceutical, Inc.ANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
50991-579IBUDONEhydrocodone bitartrate and ibuprofenPoly PharmaceuticalsANDACurrent
55700-639Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-296HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76162ORIG 2023-11-03