Application 213057

Type: ANDA
Sponsor: ZYDUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	5MG	No	No
002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	10MG	No	No
003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	20MG	No	No
004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	30MG	No	No
005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	40MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-007	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-008	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-009	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-010	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
70518-3444	Isosorbide dinitrate	Isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current
70518-3444	Isosorbide dinitrate	Isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current
70710-1148	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1148	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1149	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1149	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1150	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1150	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1151	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1151	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1152	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1152	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1501	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1501	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1502	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1502	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1503	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1503	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1504	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1504	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1505	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1505	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current

Application 213057

Related Records#

Application Products#

NDC Listings For This Application#