Application 203574
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 1.2GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7401 | Mesalamine | mesalamine Film Coated | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7401 | Mesalamine | mesalamine Film Coated | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7401 | Mesalamine | mesalamine Film Coated | Mylan Pharmaceuticals Inc. | ANDA | Current |