Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070607
Company: PERRIGO NEW YORK

Products on ANDA 070607

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070607

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-Container/Carton Labels, Labeling-Package Insert		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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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
ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Over-the-counter	No	070607	PERRIGO NEW YORK
ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Over-the-counter	Yes	018337	TARO