FDA.reportPublic FDA data

Application 212333

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOTRETINOINISOTRETINOINCAPSULE;ORAL10MGNoNo
002ISOTRETINOINISOTRETINOINCAPSULE;ORAL20MGNoNo
003ISOTRETINOINISOTRETINOINCAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0570IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
0245-0570IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
0245-0571IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
0245-0571IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
0245-0573IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
0245-0573IsotretinoinIsotretinoinUpsher-Smith Laboratories, LLCANDACurrent
68308-570IsotretinoinIsotretinoinMayne PharmaANDACurrent
68308-570IsotretinoinIsotretinoinMayne PharmaANDACurrent
68308-571IsotretinoinIsotretinoinMayne PharmaANDACurrent
68308-571IsotretinoinIsotretinoinMayne PharmaANDACurrent
68308-573IsotretinoinIsotretinoinMayne PharmaANDACurrent
68308-573IsotretinoinIsotretinoinMayne PharmaANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76356ORIG 2023-11-06
67423ORIG2021-05-06