Application 077883
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | CAPSULE;ORAL | 750MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-157 | Balsalazide Disodium | Balsalazide Disodium | AvKARE, Inc. | ANDA | Current |
| 42291-157 | Balsalazide Disodium | Balsalazide Disodium | AvKARE | ANDA | Current |
| 50268-102 | Balsalazide Disodium | Balsalazide Disodium | AvPAK | ANDA | Current |
| 50268-102 | Balsalazide Disodium | Balsalazide Disodium | AvPAK | ANDA | Current |
| 60505-2575 | Balsalazide Disodium | Balsalazide Disodium | Apotex Corp. | ANDA | Current |
| 60505-2575 | Balsalazide Disodium | Balsalazide Disodium | Apotex Corp. | ANDA | Current |
| 60505-2575 | Balsalazide Disodium | Balsalazide Disodium | Apotex Corp. | ANDA | Current |
| 60505-2575 | Balsalazide Disodium | Balsalazide Disodium | Apotex Corp. | ANDA | Current |
| 63629-8301 | Balsalazide Disodium | Balsalazide Disodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8301 | Balsalazide Disodium | Balsalazide Disodium | Bryant Ranch Prepack | ANDA | Current |