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Generated: January 18, 2019

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Details for New Drug Application (NDA): 072267

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NDA 072267 describes FENOPROFEN CALCIUM, which is a drug marketed by Am Therap, Aurolife Pharma Llc, Halsey, Par Pharm, Quantum Pharmics, Warner Chilcott, Watson Labs, Actavis Elizabeth, Dava Pharms Inc, Ivax Sub Teva Pharms, Sun Pharm Industries, Usl Pharma, Watson Labs Teva, and Xspire Pharma, and is included in thirty NDAs. It is available from four suppliers. Additional details are available on the FENOPROFEN CALCIUM profile page.

The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
Summary for 072267
Applicant:Xspire Pharma
Ingredient:fenoprofen calcium
Formulation / Manufacturing:see details
Pharmacology for NDA: 072267
Medical Subject Heading (MeSH) Categories for 072267
Suppliers and Packaging for NDA: 072267
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072267 ANDA Mylan Pharmaceuticals Inc. 0378-0471 0378-0471-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0471-01)
FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072267 ANDA Xspire Pharma, Llc 42195-471 42195-471-01 100 TABLET, FILM COATED in 1 BOTTLE (42195-471-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE
Approval Date:Aug 17, 1988TE:RLD:No

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