Details for New Drug Application (NDA): 016023
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NDA 016023 describes SYMMETREL, which is a drug marketed by Endo Pharms and is included in three NDAs. Additional details are available on the SYMMETREL profile page.
The generic ingredient in SYMMETREL is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
The generic ingredient in SYMMETREL is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 016023
| Tradename: | SYMMETREL |
| Applicant: | Endo Pharms |
| Ingredient: | amantadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016023
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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