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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070607
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN ACETAMINOPHEN 120MG 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
04/06/1987 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-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/08/2011 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

08/06/2010 SUPPL-6 Labeling

Label is not available on this site.

08/31/1992 SUPPL-3 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; 120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACEPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 018060 COSETTE
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter No 070607 PERRIGO NEW YORK
ACETAMINOPHEN ACETAMINOPHEN 120MG SUPPOSITORY;RECTAL Over-the-counter Yes 018337 TARO PHARM INDS LTD
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