Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018749
Company: MISSION PHARMA
Company: MISSION PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LITHOSTAT | ACETOHYDROXAMIC ACID | 250MG | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/31/1983 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/26/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/06/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1984 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |