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Generated: April 19, 2019

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Details for New Drug Application (NDA): 080500

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NDA 080500 describes RAUWOLFIA SERPENTINA, which is a drug marketed by Bundy, Halsey, Impax Labs, Ivax Sub Teva Pharms, Purepac Pharm, Pvt Form, Solvay, Tablicaps, Valeant Pharm Intl, and Watson Labs, and is included in twelve NDAs. Additional details are available on the RAUWOLFIA SERPENTINA profile page.

The generic ingredient in RAUWOLFIA SERPENTINA is rauwolfia serpentina root. There are eight drug master file entries for this compound. Additional details are available on the rauwolfia serpentina root profile page.
Summary for 080500
Ingredient:rauwolfia serpentina root
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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