Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075953
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERCONAZOLE | TERCONAZOLE | 0.8% | CREAM;VAGINAL | Prescription | BX | 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 |
---|---|---|---|---|---|---|---|
04/06/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075953_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/25/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
08/25/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
TERCONAZOLE
There are no Therapeutic Equivalents.