Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074916

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NDA 074916 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Onesource, P And L Dev Llc, Patheon Softgels, Pharmazone, 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, 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, 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 Lifesciences, and Xgen Pharms, and is included in one hundred and eighty-four NDAs. It is available from two hundred and forty-four 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 074916

Tradename:	IBUPROFEN
Applicant:	P And L
Ingredient:	ibuprofen
Patents:	0

Pharmacology for NDA: 074916

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 074916

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

Suppliers and Packaging for NDA: 074916

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN	ibuprofen	SUSPENSION;ORAL	074916	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1828	0121-1828-00	10 TRAY in 1 CASE (0121-1828-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1828-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Apr 30, 1999	TE:		RLD:	No

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