Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018040
Company: JANSSEN PHARMA
Company: JANSSEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONISTAT | MICONAZOLE | 10MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/04/1978 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 07/08/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/20/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 06/25/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/08/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/20/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |