Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075915
Company: PERRIGO
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIOCONAZOLE | TIOCONAZOLE | 6.5% | OINTMENT;VAGINAL | Over-the-counter | None | 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 |
---|---|---|---|---|---|---|---|
11/21/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75915.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075915.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/17/2015 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/30/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
10/10/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/09/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
TIOCONAZOLE
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 |