Details for New Drug Application (NDA): 006773
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NDA 006773 describes ARTANE, which is a drug marketed by Lederle and is included in two NDAs. Additional details are available on the ARTANE profile page.
The generic ingredient in ARTANE is trihexyphenidyl hydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.
The generic ingredient in ARTANE is trihexyphenidyl hydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.
Summary for 006773
| Tradename: | ARTANE |
| Applicant: | Lederle |
| Ingredient: | trihexyphenidyl hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 006773
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 009
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | ELIXIR;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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