Application 017874
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CON
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRANSDERM SCOP | SCOPOLAMINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 1MG/72HR | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0067-4345 | Transderm Scop | scopolamine | Novatris Consumer Health, Inc. | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-4346 | Transderm Scop | scopolamine | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 10019-553 | Transderm Scop | Scopalamine | Baxter Healthcare Corporation | NDA | Current |
| 66758-208 | Transderm Scop | scopolamine | Sandoz Inc | NDA | Current |
| 66758-208 | Transderm Scop | scopolamine | Sandoz Inc | NDA | Current |
| 66758-208 | Transderm Scop | scopolamine | Sandoz Inc | NDA | Current |