Application 207448
- Type
- ANDA
- Sponsor
- PHARM SOURCING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | SUPPOSITORY;RECTAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-2397 | Mesalamine | Mesalamine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2397 | Mesalamine | Mesalamine | Bryant Ranch Prepack | ANDA | Current |
| 64980-282 | Mesalamine | Mesalamine | Rising Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56849 | ORIG | 2018-12-20 |