Application 008848
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAMINE | METHSCOPOLAMINE BROMIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | PAMINE FORTE | METHSCOPOLAMINE BROMIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0482 | Methscopolamine Bromide | methscopolamine bromide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0168-0483 | Methscopolamine Bromide | methscopolamine bromide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 10337-061 | Pamine | methscopolamine bromide | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-062 | Pamine Forte | methscopolamine bromide | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |