FDA.reportPublic FDA data

Application 088008

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATESYRUP;ORAL1.5MG/5ML;5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4811Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromidePharmaceutical AssociatesANDACurrent
0121-4811Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromidePharmaceutical Associates, Inc.ANDACurrent
0121-4811Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromidePharmaceutical Associates, Inc.ANDACurrent
17856-0455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideATLANTIC BIOLOGICALS CORP.ANDACurrent
60432-455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideMorton Grove Pharmaceuticals, Inc.ANDACurrent
60687-278Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideAmerican Health PackagingANDACurrent
60687-278Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideAmerican Health PackagingANDACurrent
60687-278Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromideAmerican Health PackagingANDACurrent