Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020676
Company: COMBE
Company: COMBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VAGISTAT-1 | TIOCONAZOLE | 6.5% | OINTMENT;VAGINAL | Over-the-counter | None | Yes | 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 |
---|---|---|---|---|---|---|---|
02/11/1997 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020676_vagistat-1_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/21/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/2009 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020676s009ltr.pdf | |
12/12/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/09/2001 | SUPPL-4 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20676s4lbl.pdf | |
04/24/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/23/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/24/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/15/2009 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf | |
08/09/2001 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20676s4lbl.pdf |
VAGISTAT-1
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
OINTMENT;VAGINAL; 6.5%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
TIOCONAZOLE | TIOCONAZOLE | 6.5% | OINTMENT;VAGINAL | Over-the-counter | No | 075915 | PERRIGO |
VAGISTAT-1 | TIOCONAZOLE | 6.5% | OINTMENT;VAGINAL | Over-the-counter | Yes | 020676 | COMBE |