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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075077
Company: PERRIGO

Products on ANDA 075077

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075077

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75077ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75077_Acetaminophen.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2019	SUPPL-55	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/10/2016	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
11/30/2013	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
10/25/2010	SUPPL-28	Labeling		Label is not available on this site.
02/10/2005	SUPPL-6	Labeling		Label is not available on this site.
12/29/2000	SUPPL-1	Labeling		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.

TABLET, EXTENDED RELEASE;ORAL; 650MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	207229	AUROBINDO PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	211544	GRANULES
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	207035	HERITAGE PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	215486	MARKSANS PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	076200	OHM LABS
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075077	PERRIGO
ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	078569	SUN PHARM INDS LTD
TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	019872	J AND J CONSUMER INC

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