Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200923
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GYNAZOLE-1 | BUTOCONAZOLE NITRATE | 2% | CREAM;VAGINAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/18/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2015 | SUPPL-4 | Labeling-Proprietary Name Change |
Label is not available on this site. |