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Last Updated: November 18, 2024

Details for New Drug Application (NDA): 016418


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NDA 016418 describes INDERAL, which is a drug marketed by Wyeth Ayerst, Wyeth Pharms, and Ani Pharms, and is included in three NDAs. Additional details are available on the INDERAL profile page.

The generic ingredient in INDERAL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.
Summary for 016418
Tradename:INDERAL
Applicant:Wyeth Pharms
Ingredient:propranolol hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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