Application 214242
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 375MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-650 | Mesalamine | Mesalamine | American Health Packaging | ANDA | Current |
| 67877-717 | Mesalamine | Mesalamine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-717 | Mesalamine | Mesalamine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-717 | Mesalamine | Mesalamine | Ascend Laboratories, LLC | ANDA | Current |