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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090205
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;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
11/18/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-2 Labeling

Label is not available on this site.

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