← FDA Drug Approvals (Drugs@FDA)
BUTENAFINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARMA CANADA · Approved 2017-11-16
Drug application
- FDA Application #
ANDA205181- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUTENAFINE HYDROCHLORIDE
- Generic name
- BUTENAFINE HYDROCHLORIDE
- Active ingredients
- BUTENAFINE HYDROCHLORIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Marketing status
- Over-the-counter
- Sponsor
- SUN PHARMA CANADA
- Manufacturer
- TOPCO ASSOCIATES LLC
- First approval
- 2017-11-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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