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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075794
Company: PERRIGO

Products on ANDA 075794

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075794

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2016	SUPPL-45	Labeling-Container/Carton Labels		Label is not available on this site.
12/12/2014	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
11/22/2010	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
03/05/2008	SUPPL-26	Labeling		Label is not available on this site.
11/21/2006	SUPPL-22	Labeling		Label is not available on this site.
12/17/2003	SUPPL-12	Labeling		Label is not available on this site.
10/08/2003	SUPPL-8	Labeling		Label is not available on this site.
08/16/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/16/2002	SUPPL-3	Labeling		Label is not available on this site.
08/16/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/16/2002	SUPPL-1	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.

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

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

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

TABLET;ORAL; 250MG;250MG;65MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET;ORAL	Over-the-counter	No	211695	AUROBINDO PHARMA LTD
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET;ORAL	Over-the-counter	No	214039	GRANULES
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET;ORAL	Over-the-counter	No	075794	PERRIGO
EXCEDRIN (MIGRAINE RELIEF)	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET;ORAL	Over-the-counter	Yes	020802	HALEON US HOLDINGS

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