Application 078297

Type: ANDA
Sponsor: AUROBINDO PHARMA

Related Records

Company: AUROBINDO PHARMA

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
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-0550	Terbinafine	Terbinafine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-344	Terbinafine	Terbinafine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-344	Terbinafine	Terbinafine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68071-2579	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4712	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4712	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4873	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4873	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2941	Terbinafine	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2941	Terbinafine	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-243	TERBINAFINE	TERBINAFINE	direct rx	ANDA	Current