Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 075139
Company: LNK

Products on ANDA 075139

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 075139

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/1999/75139ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/075139_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/13/2020	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
11/04/2005	SUPPL-8		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/075139_S008_IBUPROFEN TABLETS.pdf
07/19/2004	SUPPL-7		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075139_S007_IBUPROFEN TABLETS.pdf
02/04/2003	SUPPL-6		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S006_IBUPROFEN TABLETS.pdf
08/05/2003	SUPPL-5		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S005_IBUPROFEN TABLETS.pdf
08/15/2002	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S004_IBUPROFEN TABLETS.pdf
02/11/2002	SUPPL-3	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf
02/11/2002	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf
08/15/2001	SUPPL-1	Manufacturing (CMC)-Manufacturing Process	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075139_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	079233	AMNEAL PHARMS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	071333	AMNEAL PHARMS NY
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	072299	CONTRACT PHARMACAL
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	075661	DR REDDYS LA
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	070481	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	079129	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	091355	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	206989	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	207052	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	No	071229	VINTAGE PHARMS
MOTRIN IB	IBUPROFEN	200MG	TABLET;ORAL	Over-the-counter	Yes	019012	J AND J CONSUMER INC