Application 020238
- Type
- NDA
- Sponsor
- MEDTECH PRODUCTS
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| TAGAMET HB | CIMETIDINE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71187 | SUPPL | 2022-06-01 |
| 71147 | SUPPL | 2022-05-25 |
| 67993 | SUPPL | 2021-06-30 |
| 67914 | SUPPL | 2021-06-28 |
| 62562 | SUPPL | 2020-04-14 |
| 62561 | SUPPL | 2020-04-14 |
| 58096 | SUPPL | 2019-03-27 |
| 58093 | SUPPL | 2019-03-27 |
| 20548 | SUPPL | 2008-07-30 |
| 2225 | SUPPL | 2008-02-13 |
| 24633 | SUPPL | 2006-10-05 |
| 12352 | SUPPL | 2005-05-17 |
| 2224 | SUPPL | 2005-05-17 |