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Details for New Drug Application (NDA): 071999

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NDA 071999 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, Hi-tech Pharmacal, 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-four NDAs. It is available from two hundred and thirty-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. Five suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for NDA: 071999

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength800MG
Approval Date:Dec 3, 1987TE:RLD:No


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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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