Application 207503
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAZOLAMIDE | ACETAZOLAMIDE | TABLET;ORAL | 125MG | No | No |
| 002 | ACETAZOLAMIDE | ACETAZOLAMIDE | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-884 | AcetaZOLAMIDE | Acetazolamide | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-884 | AcetaZOLAMIDE | Acetazolamide | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-885 | AcetaZOLAMIDE | Acetazolamide | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-885 | AcetaZOLAMIDE | Acetazolamide | Breckenridge Pharmaceutical, Inc. | ANDA | Current |