Application 018602

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	30MG	Yes	No
002	CARDIZEM	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	60MG	Yes	No
003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	90MG	Yes	No
004	CARDIZEM	DILTIAZEM HYDROCHLORIDE	TABLET;ORAL	120MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0771	Cardizem	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0771	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0771	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0771	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0771	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0771	Cardizem	Diltiazem Hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0772	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0792	Cardizem	Diltiazem Hydrochloride	Bausch Health Americas Inc.	NDA	Current
58118-1007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Clinical Solutions Wholesale, LLC	NDA AUTHORIZED GENERIC	Current
58118-1007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Clinical Solutions Wholesale, LLC	NDA AUTHORIZED GENERIC	Current
58118-1007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Clinical Solutions Wholesale, LLC	NDA AUTHORIZED GENERIC	Current
68071-3290	Diltiazem Hydrochloride	Diltiazem Hydrochloride	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68071-4242	Diltiazem Hydrochloride	Diltiazem Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4242	Diltiazem Hydrochloride	Diltiazem Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4242	Diltiazem Hydrochloride	Diltiazem Hydrochloride	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68682-006	Diltiazem Hydrochloride	Diltiazem hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-006	Diltiazem Hydrochloride	Diltiazem hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-006	Diltiazem Hydrochloride	Diltiazem hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-006	Diltiazem Hydrochloride	Diltiazem hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-006	Diltiazem Hydrochloride	Diltiazem hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70518-0783	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0783	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1096	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1096	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1096	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-1096	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2443	Diltiazem Hydrochloride	Diltiazem Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70934-559	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70934-559	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70934-854	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
71335-0579	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0579	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0579	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1001	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1001	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1001	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81994	SUPPL	2025-04-25
81952	SUPPL	2025-04-24
64892	SUPPL	2020-10-13
64884	SUPPL	2020-10-09
45911	SUPPL	2016-11-22
45943	SUPPL	2016-11-21
33511	SUPPL	2014-11-25
953	SUPPL	2010-11-30
11243	SUPPL	2010-11-22

Application 018602

Related Records#

Application Products#

NDC Listings For This Application#

Documents#