Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012179
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOSOL | ACETIC ACID, GLACIAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OTIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/17/1960 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 10/16/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/21/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/24/1985 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/06/1984 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/06/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/02/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1974 | SUPPL-5 |
Label is not available on this site. |