Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019919
Company: MEDA PHARMS
Company: MEDA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROWASA | MESALAMINE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY;RECTAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/01/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019919a_s002.pdf |
| 02/19/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |