Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077547
Company: ENCUBE
Company: ENCUBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 0.75% | 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 |
---|---|---|---|---|---|---|---|
07/13/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/14/2015 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
METRONIDAZOLE
GEL;TOPICAL; 0.75%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROGEL | METRONIDAZOLE | 0.75% | GEL;TOPICAL | Prescription | Yes | AB | 019737 | GALDERMA LABS LP |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;TOPICAL | Prescription | No | AB | 078178 | COSETTE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;TOPICAL | Prescription | No | AB | 077547 | ENCUBE |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;TOPICAL | Prescription | No | AB | 077018 | FOUGERA PHARMS |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | GEL;TOPICAL | Prescription | No | AB | 077819 | TARO |