Application 019919
- Type
- NDA
- Sponsor
- MEDA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROWASA | MESALAMINE | SUPPOSITORY;RECTAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41095 | SUPPL | 1997-08-08 |