Application 090858

Type: ANDA
Sponsor: ALKEM

Related Records

Company: ALKEM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6665	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6665	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6665	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6665	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6666	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6666	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6666	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6666	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6667	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6667	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6667	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6667	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
16714-503	Gabapentin	Gabapentin	NorthStar RxLLC	ANDA	Current
16714-504	Gabapentin	Gabapentin	NorthStar RxLLC	ANDA	Current
16714-505	Gabapentin	Gabapentin	NorthStar RxLLC	ANDA	Current
42708-056	Gabapentin	Gabapentin	QPharma Inc	ANDA	Current
42708-056	Gabapentin	Gabapentin	QPharma Inc	ANDA	Current
42708-120	Gabapentin	Gabapentin	QPharma Inc	ANDA	Current
42708-120	Gabapentin	Gabapentin	QPharma Inc	ANDA	Current
42708-120	Gabapentin	Gabapentin	QPharma Inc	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-673	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-687	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-549	Gabapentin	Gabapentin	medsource pharmaceuticals	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-0896	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2107	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2847	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3200	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3582	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-4893	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-5125	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-5125	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-5961	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50436-0223	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-0223	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-0223	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-0224	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-0224	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-0224	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
53217-268	Gabapentin	Gabapentin	Aidarex Pharmaceuticals LLC	ANDA	Current
53217-284	Gabapentin	Gabapentin	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-3363	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-3363	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7992	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-7992	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7992	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7992	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7993	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-7993	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7993	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7993	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8194	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-8194	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8195	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8195	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55695-016	Gabapentin	Gabapentin	Department of State Health Services, Pharmacy Branch	ANDA	Current
55700-544	Gabapentin	Gabapentin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents

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