Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076503
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTRET ISOTRETINOIN 30MG CAPSULE;ORAL Discontinued None 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
06/20/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076503.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2012 SUPPL-16 REMS-Modified

Label is not available on this site.

10/22/2010 SUPPL-7 REMS-Proposal

Label is not available on this site.

03/25/2010 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/20/2009 SUPPL-5 Labeling

Label is not available on this site.

11/02/2007 SUPPL-4 Labeling

Label is not available on this site.

02/06/2007 SUPPL-3 Labeling

Label is not available on this site.

02/06/2007 SUPPL-2 Labeling

Label is not available on this site.

08/12/2005 SUPPL-1 Labeling

Label is not available on this site.

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