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Last Updated: March 21, 2026

Details for New Drug Application (NDA): 214699

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NDA 214699 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, Onesource Specialty, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Guardian Drug, L Perrigo Co, Strides Pharma, Sun Pharma Canada, Tris Pharma Inc, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, Perrigo, Abbott, Adaptis, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Ph Health, Pharmobedient, Pliva, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Strides Pharma Intl, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, Pld Acquisitions Llc, Teva Pharms Usa, Torrent, Zydus Pharms, and Xgen Pharms, and is included in one hundred and eighty-three NDAs. It is available from two hundred and thirty-four suppliers. 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. One supplier is listed for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for 214699

Tradename:	IBUPROFEN
Applicant:	Alkem Labs Ltd
Ingredient:	ibuprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 214699

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Sep 13, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Sep 13, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Sep 13, 2021	TE:	AB	RLD:	No

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