FDA.reportPublic FDA data

Application 040655

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-3890Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0603-3890Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenPar PharmaceuticalANDACurrent
0603-3890Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenPar PharmaceuticalANDACurrent
0603-3890Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenPar PharmaceuticalANDACurrent
33261-053Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
45865-605Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenMedsource PharmaceticalsANDACurrent
50090-1517Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenA-S Medication SolutionsANDACurrent
50090-1517Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenA-S Medication SolutionsANDACurrent
50090-1518Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenA-S Medication SolutionsANDACurrent
50090-1518Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenA-S Medication SolutionsANDACurrent
51079-777Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenMylan Institutional Inc.ANDACurrent
51655-899hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenNorthwind PharmaceuticalsANDACurrent
53002-0156Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenRPK Pharmaceuticals, Inc.ANDACurrent
53002-0156Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenRPK Pharmaceuticals, Inc.ANDACurrent
55700-261Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-261Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-202Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
63739-704Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenMcKesson Corporation dba SKY PackagingANDACurrent
63739-704Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenMcKesson CorporationANDACurrent
66336-670Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenDispensing Solutions, Inc.ANDACurrent
67296-0515HYDROCODONE BITARTRATE AND ACETAMINOPHENhydrocodone bitartrate and acetaminophenRedPharm Drug Inc.ANDACurrent
68788-9137Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76163ORIG 2023-11-03