Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072344
Company: G AND W LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter 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
04/02/2015 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2010 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/29/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/06/1993 SUPPL-1 Labeling

Label is not available on this site.

ACEPHEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUPPOSITORY;RECTAL; 325MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter No 072344 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 325MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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