Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075010
Company: LNK

Products on ANDA 075010

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 075010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075010_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2015	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
11/04/2005	SUPPL-7			Label is not available on this site.
07/19/2004	SUPPL-6			Label is not available on this site.
02/04/2003	SUPPL-5			Label is not available on this site.
08/05/2003	SUPPL-4			Label is not available on this site.
08/15/2002	SUPPL-3	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075010_S003_IBUPROFEN_TABLETS.pdf
09/27/2001	SUPPL-2	Manufacturing (CMC)-Manufacturing Process	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075010_S002_IBUPROFEN_TABLETS.pdf
11/20/2000	SUPPL-1	Manufacturing (CMC)-Formulation	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075010_S001_IBUPROFEN TABLETS.pdf

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