FDA.reportPublic FDA data

Application 076485

Type
ANDA
Sponsor
DOUGLAS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYORISANISOTRETINOINCAPSULE;ORAL10MGNoNo
002MYORISANISOTRETINOINCAPSULE;ORAL20MGNoNo
003MYORISANISOTRETINOINCAPSULE;ORAL40MGNoNo
004MYORISANISOTRETINOINCAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61748-301MyorisanisotretinoinVersaPharm, Inc. ANDACurrent
61748-301MyorisanisotretinoinAkorn Operating Company LLCANDACurrent
61748-301MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-301MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-302MyorisanisotretinoinVersaPharm, Inc. ANDACurrent
61748-302MyorisanisotretinoinAkorn Operating Company LLCANDACurrent
61748-302MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-302MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-303MyorisanisotretinoinVersaPharm, Inc. ANDACurrent
61748-303MyorisanisotretinoinAkorn Operating Company LLCANDACurrent
61748-303MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-303MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-304MyorisanisotretinoinVersaPharm, Inc. ANDACurrent
61748-304MyorisanisotretinoinAkorn Operating Company LLCANDACurrent
61748-304MyorisanisotretinoinVersapharm IncorporatedANDACurrent
61748-304MyorisanisotretinoinVersapharm IncorporatedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24056ORIG2015-07-02
43081ORIG2013-05-10