← FDA Drug Approvals (Drugs@FDA)

TERBINAFINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARMA CANADA · Approved 2007-07-02

Drug application

FDA Application #
ANDA077511
Application type
Abbreviated New Drug Application (Generic)
Brand name
TERBINAFINE HYDROCHLORIDE
Generic name
TERBINAFINE HYDROCHLORIDE
Active ingredients
TERBINAFINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Marketing status
Over-the-counter
Sponsor
SUN PHARMA CANADA
Manufacturer
Genomma Lab USA, Inc.
First approval
2007-07-02

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown