Application 206582

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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
59726-297OmeprazoleOmeprazole magnesiumP & L Development, LLCANDACurrent
59726-297OmeprazoleOmeprazole magnesiumP & L Development, LLCANDACurrent
59726-737OmeprazoleOmeprazole magnesiumP & L Development, LLCANDACurrent
59726-737OmeprazoleOmeprazole magnesiumP & L Development, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50730ORIG2017-12-18