Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216323
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 0.75% | 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 |
---|---|---|---|---|---|---|---|
07/12/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METRONIDAZOLE
GEL;VAGINAL; 0.75%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROGEL-VAGINAL | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | Yes | AB | 020208 | BAUSCH |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 216323 | COSETTE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 215610 | ENCUBE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 215794 | GLENMARK PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 211786 | PADAGIS ISRAEL |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;VAGINAL | Prescription | No | AB | 213648 | SOLARIS PHARMA CORP |