Application 202717

Type: ANDA
Sponsor: ACCORD HLTHCARE

Related Records

Company: ACCORD HLTHCARE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	TABLET;ORAL	EQ 10MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
16729-119	Montelukast Sodium	Montelukast Sodium	Accord Healthcare Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-762	Montelukast Sodium	Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-2176	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
50090-5403	Montelukast Sodium	Montelukast Sodium	A-S Medication Solutions	ANDA	Current
53002-1441	Montelukast Sodium	Montelukast Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1441	Montelukast Sodium	Montelukast Sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
61919-009	MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63187-781	Montelukast Sodium	Montelukast Sodium	Proficient Rx LP	ANDA	Current
63629-8106	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8106	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3355	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4047	Montelukast Sodium	Montelukast Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9438	Montelukast Sodium	Montelukast Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0172	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0331	Montelukast Sodium	Montelukast Sodium	REMEDYREPACK INC.	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-202	Montelukast Sodium	Montelukast Sodium	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0514	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1599	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1599	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current