Application 017453
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROGLYCEM | DIAZOXIDE | SUSPENSION;ORAL | 50MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
| 0575-6200 | Proglycem | diazoxide | Teva Pharmaceuticals USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79146 | SUPPL | 2024-07-22 |
| 79128 | SUPPL | 2024-07-22 |
| 73048 | SUPPL | 2022-12-27 |
| 73020 | SUPPL | 2022-12-23 |
| 33274 | SUPPL | 2015-09-21 |
| 593 | SUPPL | 2015-09-21 |
| 33273 | SUPPL | 2009-01-02 |
| 592 | SUPPL | 2008-12-24 |
| 13145 | SUPPL | 2004-01-22 |