Application 020238
- Type
- NDA
- Sponsor
- MEDTECH PRODUCTS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAGAMET HB | CIMETIDINE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | TAGAMET HB | CIMETIDINE | TABLET;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |