Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070608
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 650MG 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
12/01/1986 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
09/24/2015 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/10/2011 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

08/06/2010 SUPPL-8 Labeling

Label is not available on this site.

08/31/1992 SUPPL-5 Labeling

Label is not available on this site.

10/23/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ACETAMINOPHEN

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

SUPPOSITORY;RECTAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 018060 G AND W LABS
ACEPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 072237 G AND W LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter No 070608 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 650MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARMS NORTH

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