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Details for New Drug Application (NDA): 071265

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NDA 071265 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Sofgen Pharms, Strides Pharma, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Arise, P And L, Taro, Perrigo, Abbott, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Hec Pharm, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Pliva, Purepac Pharm, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, and Xgen Pharms, and is included in one hundred and sixty-three NDAs. Additional details are available on the IBUPROFEN profile page.

The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for 071265

Tradename:	IBUPROFEN
Applicant:	Contract Pharmacal
Ingredient:	ibuprofen
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 071265

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Oct 15, 1986	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 10, 1987	TE:		RLD:	No

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