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Details for New Drug Application (NDA): 076460

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NDA 076460 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Vintage Pharms, Marksans Pharma, Watson Labs, Sandoz, Sun Pharm Inds, Superpharm, LNK, Dr Reddys Labs Inc, Granules India Ltd, Perrigo R And D, Actavis Mid Atlantic, Perrigo, Ohm Labs, Mcneil, Purepac Pharm, Halsey, Par Pharm, Lederle, Strides Pharma, Contract Pharmacal, Northstar Hlthcare, Amneal Pharms Ny, Aurolife Pharma Llc, P And L Dev Llc, Ivax Sub Teva Pharms, Teva, Mylan, Abbott, Tris Pharma Inc, Avema Pharma, Dr Reddys La, OHM, Leiner, Pliva, Humanwell Puracap, Granules India, J And J Consumer Inc, Bionpharma Inc, Merro Pharm, Sofgen Pharms, Dr Reddys Labs Ltd, and Exela Pharma Science, and is included in one hundred and forty-three NDAs. It is available from two hundred and thirty-three suppliers. Additional details are available on the IBUPROFEN profile page.

The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for NDA: 076460

Avema Pharma
Therapeutic Class:Analgesics
Anti-inflammatory Agents

Suppliers and Packaging for NDA: 076460

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076460 ANDA The Kroger Co. 30142-186 30142-186-05 500 TABLET in 1 BOTTLE, PLASTIC (30142-186-05)
TABLET;ORAL 076460 ANDA The Kroger Co. 30142-235 30142-235-05 500 TABLET, COATED in 1 BOTTLE, PLASTIC (30142-235-05)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Nov 26, 2003TE:RLD:No

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