Application 211732

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69230-318OmeprazoleOmeprazoleCamber Consumer CareANDACurrent
69230-318OmeprazoleOmeprazoleCamber Consumer CareANDACurrent
69230-318OmeprazoleOmeprazoleCamber Consumer Care IncANDACurrent
69230-318OmeprazoleOmeprazoleCamber Consumer Care IncANDACurrent