Application 021392

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	120MG	Yes	No
002	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	180MG	Yes	No
003	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	Yes	No
004	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	No
005	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	360MG	Yes	No
006	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	420MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2046	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2048	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2049	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
68682-704	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-704	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2451	Diltiazem Hydrochloride	Diltiazem Hydrochloride Extended-Release Tablets	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81965	SUPPL	2025-04-24
81964	SUPPL	2025-04-24
45917	SUPPL	2016-11-22
45937	SUPPL	2016-11-21
15352	SUPPL	2015-04-14
27649	SUPPL	2015-03-25
27648	SUPPL	2010-11-30
36809	SUPPL	2010-11-22
21631	SUPPL	2007-07-06
15351	SUPPL	2007-05-01
5239	SUPPL	2007-05-01
21630	ORIG	2005-06-27
27647	SUPPL	2004-04-07
15350	SUPPL	2004-04-05
15349	ORIG	2003-02-06

Application 021392

Related Records#

Application Products#

NDC Listings For This Application#

Documents#