Application 078060
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 800MG;160MG | No | No |
| 002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 400MG;80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43353-368 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 55695-008 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Department of State Health Services, Pharmacy Branch | ANDA | Current |
| 63187-285 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 67046-715 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Contract Pharmacy Services-PA | ANDA | Current |
| 68788-9086 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals | ANDA | Current |
| 68788-9086 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 75921-578 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Life Line Home Care Services, Inc. | ANDA | Current |