Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202312
Company: GRANULES

Products on ANDA 202312

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

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; 200MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	Yes	018989	HALEON US HOLDINGS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	072299	ADAPTIS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	072199	AMNEAL PHARMS NY
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	208865	AUROBINDO PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	076460	AVEMA PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	075661	DR REDDYS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	076117	DR REDDYS LABS INC
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	202312	GRANULES
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	079174	GRANULES INDIA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	075010	LNK
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	075139	LNK
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	091237	MARKSANS PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	091239	MARKSANS PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	073019	MCNEIL
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	072096	PERRIGO
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	077349	PERRIGO R AND D
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	207095	SHANDONG XINHUA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	079129	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	091355	STRIDES PHARMA
MOTRIN IB	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	Yes	019012	KENVUE BRANDS