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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072237
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL 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
03/27/1992 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
11/10/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/10/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/24/2013 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/19/2010 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/29/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/10/1992 SUPPL-1 Labeling

Label is not available on this site.

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