Application 020062

Type: NDA
Sponsor: BAUSCH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA	Current
71335-2029	Diltiazem HCl CD	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82019	SUPPL	2025-04-28
81953	SUPPL	2025-04-24
62851	SUPPL	2020-05-08
62350	SUPPL	2020-03-27
48412	SUPPL	2017-05-17
45914	SUPPL	2016-11-22
45940	SUPPL	2016-11-21
45087	SUPPL	2016-06-22
1958	SUPPL	2010-11-30
12165	SUPPL	2010-11-22
41138	SUPPL	2001-07-13

Application 020062

Related Records#

Application Products#

NDC Listings For This Application#

Documents#