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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074978

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NDA 074978 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, 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-five 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 sixty-three 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: 074978

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

Pharmacology for NDA: 074978

Suppliers and Packaging for NDA: 074978

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN
ibuprofen
SUSPENSION;ORAL 074978 ANDA Actavis Pharma, Inc. 0472-1270 0472-1270-16 473 mL in 1 BOTTLE (0472-1270-16)
IBUPROFEN
ibuprofen
SUSPENSION;ORAL 074978 ANDA Actavis Pharma, Inc. 0472-1270 0472-1270-94 1 BOTTLE in 1 CARTON (0472-1270-94) > 118 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Mar 25, 1998TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Novartis
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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