Application 018679
- Type
- NDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIMETHOPRIM | TRIMETHOPRIM | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51407-257 | Trimethoprim | Trimethoprim | Golden State Medical Supply, Inc. | NDA | Current |
| 51407-257 | Trimethoprim | Trimethoprim | Golden State Medical Supply, Inc. | NDA | Current |
| 51862-486 | Trimethoprim | Trimethoprim | Mayne Pharma | NDA | Current |
| 51862-486 | Trimethoprim | Trimethoprim | Mayne Pharma | NDA | Current |