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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021392-001	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-002	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-003	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-004	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-005	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-006	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021392-001	AB
N021392-002	AB
N021392-003	AB
N021392-004	AB
N021392-005	AB
N021392-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N021392-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021392-006	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardizem LA	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	3e180dc7-c871-4efc-8755-cae882976c8d	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392 ndc (product): 0187-2049 ndc (product): 0187-2048 ndc (product): 0187-2047 ndc (product): 0187-2046 ndc (product): 0187-2050 ndc (product): 0187-2045
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS	Oceanside Pharmaceuticals	73b3607a-99d0-44d8-92ef-0074684c9d7d	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392 ndc (product): 68682-709 ndc (product): 68682-705 ndc (product): 68682-708 ndc (product): 68682-706 ndc (product): 68682-704 ndc (product): 68682-707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-2045	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
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
0187-2046	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	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2047	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	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	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Valeant Pharmaceuticals N	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health US LLC	NDA	Current
0187-2050	Cardizem LA	Diltiazem Hydrochloride	Bausch Health Americas, Inc.	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