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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079205

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NDA 079205 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Taro, Vintage Pharms, Marksans Pharma, Watson Labs, Sandoz, Sun Pharm Inds, Superpharm, LNK, Dr Reddys Labs Inc, Granules India Ltd, Aiping Pharm Inc, Perrigo R And D, Actavis Mid Atlantic, L Perrigo Co, 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 Pharms Inc, Hi-tech Pharmacal, Abbott, Mylan, Tris Pharma Inc, Perrigo, 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-seven NDAs. It is available from two hundred and forty-six 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. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for NDA: 079205

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 079205

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN
ibuprofen
CAPSULE;ORAL 079205 ANDA L Perrigo Company 0113-0131 0113-0131-49 1 BOTTLE in 1 CARTON (0113-0131-49) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
IBUPROFEN
ibuprofen
CAPSULE;ORAL 079205 ANDA Walgreen Company 0363-0003 0363-0003-16 1 BOTTLE in 1 CARTON (0363-0003-16) > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Jun 26, 2009TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
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