Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204651
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
03/14/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METRONIDAZOLE
GEL;TOPICAL; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROGEL | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | Yes | AB | 021789 | GALDERMA LABS LP |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 212646 | ALEMBIC |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 216692 | COSETTE |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 204651 | TARO |