FDA.reportPublic FDA data

Application 088017

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

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
0472-1030Hydromethydrocodone bitartrate and homatropine methylbromideActavis Pharma, Inc.ANDACurrent
0472-1030Hydromethydrocodone bitartrate and homatropine methylbromideActavis Pharma, Inc.ANDACurrent
0472-1030Hydromethydrocodone bitartrate and homatropine methylbromideActavis Pharma, Inc.ANDACurrent