Details for New Drug Application (NDA): 017661
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NDA 017661 describes TAVIST-1, which is a drug marketed by Haleon Us Holdings and Novartis and is included in two NDAs. Additional details are available on the TAVIST-1 profile page.
The generic ingredient in TAVIST-1 is clemastine fumarate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
The generic ingredient in TAVIST-1 is clemastine fumarate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 017661
| Tradename: | TAVIST-1 |
| Applicant: | Novartis |
| Ingredient: | clemastine fumarate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017661
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1.34MG | ||||
| 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 | 1.34MG | ||||
| Approval Date: | Aug 21, 1992 | TE: | RLD: | No | |||||
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