Application 206534

Type: ANDA
Sponsor: ZYDUS PHARMS

Related Records

Company: ZYDUS PHARMS

Application Products

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	Labeler	Marketing category	Status
50090-6155	diltiazem hydrochloride	diltiazem hydrochloride	A-S Medication Solutions	ANDA	Current
68382-595	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-595	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-595	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-596	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-596	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-596	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-597	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-597	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-597	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-598	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-598	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-598	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-599	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-599	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-599	diltiazem hydrochloride	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-7634	diltiazem hydrochloride	diltiazem hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7634	diltiazem hydrochloride	diltiazem hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2071	diltiazem hydrochloride	diltiazem hydrochloride	REMEDYREPACK INC.	ANDA	Current
70771-1030	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1030	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1030	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1031	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1031	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1031	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1032	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1032	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1032	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1033	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1033	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1033	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1034	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1034	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1034	diltiazem hydrochloride	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents

Document	Submission type	Date
49367	ORIG	2017-08-15