Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076200
Company: OHM LABS

Products on ANDA 076200

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 076200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2002	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76200.apd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s000_AcetaminophenTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2015	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
09/25/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-19	Labeling-Container/Carton Labels		Label is not available on this site.
07/28/2010	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
01/22/2010	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.
11/23/2009	SUPPL-14	Labeling-Container/Carton Labels		Label is not available on this site.
02/17/2009	SUPPL-12	Labeling		Label is not available on this site.
08/11/2004	SUPPL-5		Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076200_S005_AcetaminophenTOC.cfm
12/03/2002	SUPPL-4	Manufacturing (CMC)-Packaging	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
12/03/2002	SUPPL-3	Manufacturing (CMC)-Facility	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
12/03/2002	SUPPL-2	Manufacturing (CMC)-Facility	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001s002s003s004_AcetaminophenTOC.cfm
10/15/2002	SUPPL-1	Manufacturing (CMC)-Control	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076200_s001_AcetaminophenTOC.cfm

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