Application 206641

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
006	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	420MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-745	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-746	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-747	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-748	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-749	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-750	TIADYLT ER	diltiazem hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1035	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1036	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1037	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1038	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1039	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1040	TIADYLT ER	diltiazem hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents

Document	Submission type	Date
49481	ORIG	2017-08-21