FDA.reportPublic FDA data

Application 040613

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideAtlantic Biologicals CorpsANDACurrent
21695-869Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideRebel Distributors CorpANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide101196749ANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideAkornANDACurrent