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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 070745

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NDA 070745 describes IBU, which is a drug marketed by Abbott, Basf, Alra, Pliva, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Strides Pharma, Guardian Drug, L Perrigo Co, Taro, Tris Pharma Inc, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, Perrigo, Adaptis, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Endo Operations, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Northstar Hlthcare, Norvium Bioscience, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, Pld Acquisitions Llc, Teva Pharms Usa, Xgen Pharms, Avet Lifesciences, Luitpold, and Mylan Institutional, and is included in one hundred and ninety-six NDAs. Additional details are available on the IBU profile page.

The generic ingredient in IBU is ibutilide fumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.

Summary for 070745

Tradename:	IBU
Applicant:	Basf
Ingredient:	ibuprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 070745

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jul 23, 1986	TE:		RLD:	No

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