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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214836
Company: L PERRIGO CO

Products on ANDA 214836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214836

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214836Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2025	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
10/22/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/22/2025	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

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

ACETAMINOPHEN AND IBUPROFEN

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;125MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218359	AUROBINDO PHARMA LTD
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216999	BIONPHARMA
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218247	DR REDDYS
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218311	GLENMARK PHARMS LTD
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216592	GRANULES
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	214836	L PERRIGO CO
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216994	MARKSANS PHARMA
ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	Yes	211733	HALEON US HOLDINGS

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