Application 012945
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIAMOX | ACETAZOLAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0555-0513 | Acetazolamide | Acetazolamide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 51285-754 | Diamox Sequels | Acetazolamide | Teva Women's Health, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79712 | SUPPL | 2024-09-24 |
| 79696 | SUPPL | 2024-09-23 |
| 71083 | SUPPL | 2022-05-17 |
| 71076 | SUPPL | 2022-05-16 |
| 20040 | SUPPL | 2015-01-28 |
| 20039 | SUPPL | 2015-01-28 |
| 33098 | SUPPL | 2005-03-18 |
| 12043 | SUPPL | 2005-03-18 |
| 10828 | SUPPL | 2005-03-18 |
| 349 | SUPPL | 2005-03-18 |