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Details for New Drug Application (NDA): 088831

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NDA 088831 describes PHRENILIN FORTE, which is a drug marketed by Valeant and is included in one NDA. Additional details are available on the PHRENILIN FORTE profile page.

The generic ingredient in PHRENILIN FORTE is acetaminophen; butalbital. There are sixty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for NDA: 088831

acetaminophen; butalbital

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength650MG;50MG
Approval Date:Jun 19, 1985TE: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.