Application 208783

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	No	No
004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No
005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8379	diltiazem hydrochloride	diltiazem hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8380	diltiazem hydrochloride	diltiazem hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8381	diltiazem hydrochloride	diltiazem hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50742-248	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-248	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-248	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-248	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-249	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-249	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-249	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-249	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-250	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-250	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-250	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-250	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-251	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-251	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-251	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-251	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-252	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-252	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-252	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-252	diltiazem hydrochloride	diltiazem hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current
68788-7870	diltiazem hydrochloride	diltiazem hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7870	diltiazem hydrochloride	diltiazem hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3484	diltiazem hydrochloride	diltiazem hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1776	diltiazem hydrochloride	diltiazem hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1776	diltiazem hydrochloride	diltiazem hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1897	diltiazem hydrochloride	diltiazem hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2089	diltiazem hydrochloride	diltiazem hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-409	Cardizem	Diltiazem HCL ER	Direct_Rx	ANDA	Current

Application 208783

Related Records#

Application Products#

NDC Listings For This Application#