Last Updated: September 28, 2026

Details for New Drug Application (NDA): 203599

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NDA 203599 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, Onesource, 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, Rubicon Research, Perrigo, Abbott, Adaptis, Alkem Labs Ltd, Allied, 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, Pliva, Purepac Pharm, Rising, Sandoz, Senores Pharms, 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 Lifesciences, and Xgen Pharms, and is included in one hundred and eighty-four NDAs. It is available from two hundred and forty-one suppliers. Additional details are available on the IBUPROFEN profile page.

The generic ingredient in IBUPROFEN is ibuprofen sodium. There are eight 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 203599

Tradename:	IBUPROFEN
Applicant:	Sofgen Pharms
Ingredient:	ibuprofen
Patents:	0

Pharmacology for NDA: 203599

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 203599

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

Suppliers and Packaging for NDA: 203599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN	ibuprofen	CAPSULE;ORAL	203599	ANDA	L. Perrigo Company	0113-0298	0113-0298-27	1 BOTTLE in 1 CARTON (0113-0298-27) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
IBUPROFEN	ibuprofen	CAPSULE;ORAL	203599	ANDA	L. Perrigo Company	0113-0298	0113-0298-58	1 BOTTLE in 1 CARTON (0113-0298-58) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:	Sep 7, 2016	TE:		RLD:	No

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