Application 202304

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No
003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8262	bupropion	bupropion hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43547-288	bupropion	Bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-288	bupropion	Bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-288	bupropion	Bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-288	bupropion	Bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-289	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-289	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-289	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-289	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-290	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-290	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-290	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
43547-290	bupropion	bupropion hydrochloride	Solco Healthcare US LLC	ANDA	Current
50090-3854	bupropion	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3854	bupropion	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3854	bupropion	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3854	bupropion	bupropion hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0289	bupropion	bupropion hydrochloride	Unit Dose Services	ANDA	Current
51655-357	bupropion	bupropion hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-357	bupropion	bupropion hydrochloride	Northwind Pharmaceuticals	ANDA	Current
55700-644	bupropion	bupropion hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-644	bupropion	bupropion hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-644	bupropion	bupropion hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63629-8036	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8036	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8036	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-5214	bupropion	bupropion hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5214	bupropion	bupropion hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7249	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7249	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7249	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7249	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7283	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7283	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7283	bupropion	bupropion hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1644	bupropion	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1644	bupropion	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2641	bupropion	Bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2641	bupropion	Bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2641	bupropion	Bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2641	bupropion	Bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3318	bupropion	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3318	bupropion	bupropion hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-151	bupropion	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-151	bupropion	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-151	bupropion	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-151	bupropion	bupropion hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-565	bupropion	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71205-565	bupropion	bupropion hydrochloride	Proficient Rx LP	ANDA	Current
71335-0785	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0785	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0785	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0785	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0801	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0801	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0801	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1622	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1622	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1622	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1622	bupropion	bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-057	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	ANDA	Current

Application 202304

Related Records#

Application Products#

NDC Listings For This Application#