Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076043
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERCONAZOLE | TERCONAZOLE | 0.4% | CREAM;VAGINAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/19/2005 | 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 |
---|---|---|---|---|---|
08/20/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
TERCONAZOLE
CREAM;VAGINAL; 0.4%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERCONAZOLE | TERCONAZOLE | 0.4% | CREAM;VAGINAL | Prescription | No | AB | 076712 | FOUGERA PHARMS |
TERCONAZOLE | TERCONAZOLE | 0.4% | CREAM;VAGINAL | Prescription | No | AB | 076043 | TARO |