Details for New Drug Application (NDA): 008848
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NDA 008848 describes PAMINE FORTE, which is a drug marketed by Fougera Pharms and is included in one NDA. Additional details are available on the PAMINE FORTE profile page.
The generic ingredient in PAMINE FORTE is methscopolamine bromide. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.
The generic ingredient in PAMINE FORTE is methscopolamine bromide. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the methscopolamine bromide profile page.
Summary for 008848
| Tradename: | PAMINE FORTE |
| Applicant: | Fougera Pharms |
| Ingredient: | methscopolamine bromide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
Profile for product number 002
| 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| DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Mar 25, 2003 | TE: | RLD: | No | |||||
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