Details for New Drug Application (NDA): 080723
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NDA 080723 describes RESERPINE, which is a drug marketed by Barr, Bell Pharma, Bundy, Cycle, Elkins Sinn, Everylife, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Marshall Pharma, Mk Labs, Mylan, Pharmavite, Purepac Pharm, Pvt Form, Rexall, Sandoz, Solvay, Tablicaps, Teva, Valeant Pharm Intl, Watson Labs, Whiteworth Town Plsn, West Ward, Ivax Pharms, Par Pharm, Sun Pharm Industries, and Lederle, and is included in forty-one NDAs. Additional details are available on the RESERPINE profile page.
The generic ingredient in RESERPINE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
The generic ingredient in RESERPINE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 080723
| Tradename: | RESERPINE |
| Applicant: | Whiteworth Town Plsn |
| Ingredient: | reserpine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080723
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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