Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205181
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTENAFINE HYDROCHLORIDE | BUTENAFINE HYDROCHLORIDE | 1% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/16/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205181Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/205181Orig1_Approval_Pkg.pdf |
BUTENAFINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL; 1%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| BUTENAFINE HYDROCHLORIDE | BUTENAFINE HYDROCHLORIDE | 1% | CREAM;TOPICAL | Over-the-counter | No | 205181 | TARO |
| LOTRIMIN ULTRA | BUTENAFINE HYDROCHLORIDE | 1% | CREAM;TOPICAL | Over-the-counter | Yes | 021307 | BAYER HEALTHCARE LLC |