Application 077714

Type: ANDA
Sponsor: BRECKENRIDGE PHARM

Related Records

Company: BRECKENRIDGE PHARM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	TABLET;ORAL	EQ 250MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-906	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-893	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1048	Terbinafine Hydrochloride	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1048	Terbinafine Hydrochloride	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
51655-364	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-364	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51991-526	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-526	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-526	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-526	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
60429-222	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-222	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-222	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Golden State Medical Supply	ANDA	Current
60429-222	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-1993	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1993	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1993	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-4500	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4500	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4500	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4578	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4578	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7187	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7187	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7187	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7187	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Preferred Pharmaceuticals	ANDA	Current
68788-7187	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1743	Terbinafine Hydrochloride	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1743	Terbinafine Hydrochloride	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1743	Terbinafine Hydrochloride	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1743	Terbinafine Hydrochloride	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-947	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-127	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-127	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-127	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-127	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-127	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0918	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0918	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0918	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current