Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075945
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMNESTEEM ISOTRETINOIN 10MG CAPSULE;ORAL Prescription AB No No
AMNESTEEM ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB No No
AMNESTEEM ISOTRETINOIN 40MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/08/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75945ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2017 SUPPL-34 REMS - MODIFIED - D-N-A

Label is not available on this site.

07/08/2016 SUPPL-33 REMS-Modified

Label is not available on this site.

02/04/2016 SUPPL-32 REMS-Modified

Label is not available on this site.

09/03/2015 SUPPL-31 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

12/16/2015 SUPPL-28 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/12/2012 SUPPL-26 REMS-Modified

Label is not available on this site.

04/12/2012 SUPPL-25 REMS

Label is not available on this site.

04/12/2012 SUPPL-22 REMS-Modified

Label is not available on this site.

04/12/2012 SUPPL-17 REMS-Modified

Label is not available on this site.

04/12/2012 SUPPL-16 REMS-Modified

Label is not available on this site.

10/22/2010 SUPPL-15 REMS-Proposal

Label is not available on this site.

03/25/2010 SUPPL-14 Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/075945Orig1s014.pdf
11/02/2007 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/075945Orig1s011.pdf
02/06/2007 SUPPL-10 Labeling

Label is not available on this site.

08/12/2005 SUPPL-9 Labeling

Label is not available on this site.

08/25/2005 SUPPL-6 Labeling

Label is not available on this site.

08/25/2005 SUPPL-5 Labeling

Label is not available on this site.

02/27/2003 SUPPL-2 Labeling

Label is not available on this site.

AMNESTEEM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB 076356 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB 202099 DR REDDYS LABS LTD

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB 076135 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB 202099 DR REDDYS LABS LTD

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB 076135 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB 202099 DR REDDYS LABS LTD

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