FDA.reportPublic FDA data

Application 075945

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6611AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6612AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent
0378-6614AmnesteemisotretinoinMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24051ORIG2015-07-02
43038SUPPL2012-03-28
22522SUPPL2012-03-28
44280ORIG2003-12-17
31049ORIG2002-11-08