Application 214585
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63304-089 | Mesalamine | Mesalamine | Sun Pharmaceutical Industries Inc. | ANDA | Current |
| 63304-089 | Mesalamine | Mesalamine | Sun Pharmaceutical Industries Inc. | ANDA | Current |
| 63304-089 | Mesalamine | Mesalamine | Sun Pharmaceutical Industries Inc. | ANDA | Current |