Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018988
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASOCIDIN | PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM | EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/26/1988 | 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 |
|---|---|---|---|---|---|
| 12/26/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/09/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/10/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |