Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017869
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNDUSCEIN-25 | FLUORESCEIN SODIUM | 25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/10/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 02/14/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/25/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/15/1982 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/27/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |