Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013934
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STOXIL | IDOXURIDINE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/1964 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 06/25/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/20/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 05/03/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/29/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |