Application 200908

Type: ANDA
Sponsor: PAR FORM

Related Records

Company: PAR FORM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8130	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8130	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8130	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8131	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8131	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8131	Labetalol HCL	Labetalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
49884-122	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-122	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-123	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-123	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-124	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-124	Labetalol HCL	Labetalol Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
50090-1161	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1161	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1161	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1290	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1291	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1291	Labetalol HCL	Labetalol Hydrochloride	A-S Medication Solutions	ANDA	Current
60760-628	Labetalol HCL	Labetalol Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
63629-2211	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2211	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2212	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2212	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2213	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2213	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2214	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2214	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2215	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2215	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2216	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2216	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9185	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-1546	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1546	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1546	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1546	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1546	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3411	Labetalol HCL	Labetalol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-913	Labetalol HCL	Labetalol Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1410	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1410	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2063	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2145	Labetalol HCL	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current