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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210602

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NDA 210602 describes IBUPROFEN, which is a drug marketed by 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, Aptapharma Inc, Arise, P And L, Padagis Us, Pai Holdings Pharm, Perrigo, Abbott, 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, Pliva, 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, and Xgen Pharms, and is included in one hundred and seventy-eight NDAs. It is available from two hundred and thirty 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 210602

Tradename:	IBUPROFEN
Applicant:	Aptapharma Inc
Ingredient:	ibuprofen
Patents:	0

Pharmacology for NDA: 210602

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 210602

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

Suppliers and Packaging for NDA: 210602

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN	ibuprofen	SUSPENSION;ORAL	210602	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1022	0121-1022-00	10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE
IBUPROFEN	ibuprofen	SUSPENSION;ORAL	210602	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1022	0121-1022-05	10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Nov 23, 2018	TE:		RLD:	No

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