← FDA Drug Approvals (Drugs@FDA)
TERBINAFINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GEDEON RICHTER USA · Approved 2005-03-11
Drug application
- FDA Application #
ANDA077065- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TERBINAFINE HYDROCHLORIDE
- Generic name
- Terbinafine Hydrochloride
- Active ingredients
- TERBINAFINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- GEDEON RICHTER USA
- First approval
- 2005-03-11
Source
- Authoritative
- Drugs@FDA application overview
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