Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216795
Company: ENCUBE
Company: ENCUBE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 1.3% | GEL;VAGINAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216795Orig1s000TAltr.pdf |
METRONIDAZOLE
GEL;VAGINAL; 1.3%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 1.3% | GEL;VAGINAL | Prescription | No | AB | 216795 | ENCUBE |
| NUVESSA | METRONIDAZOLE | 1.3% | GEL;VAGINAL | Prescription | Yes | AB | 205223 | CHEMO RESEARCH SL |