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Details for New Drug Application (NDA): 071265

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NDA 071265 describes PROFEN, which is a drug marketed by Contract Pharmacal and Alcon and is included in two NDAs. It is available from one supplier. Additional details are available on the PROFEN profile page.

The generic ingredient in PROFEN is suprofen. There are four drug master file entries for this compound. Additional details are available on the suprofen profile page.

Summary for NDA: 071265

Tradename:
PROFEN
Applicant:
Contract Pharmacal
Ingredient:
ibuprofen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 071265

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROFEN
ibuprofen
TABLET;ORAL 071265 ANDA Contract Pharmacal Corp. 10267-3846 10267-3846-2 250 TABLET in 1 BOTTLE (10267-3846-2)
PROFEN
ibuprofen
TABLET;ORAL 071265 ANDA Contract Pharmacal Corp. 10267-3852 10267-3852-2 250 TABLET in 1 BOTTLE (10267-3852-2)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Oct 15, 1986TE: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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