Application 020027

Type: NDA
Sponsor: BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020027-001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-10-24
N020027-003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1995-08-18

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020027-001	CARDIZEM	5MG/ML	INJECTABLE / INJECTION	RLD	1991-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020027-001	CARDIZEM	5MG/ML	INJECTABLE / INJECTION	RLD	1991-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	bb32d681-9a83-431e-9984-a5cee2c94852	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	839af3af-4040-4cf4-8d4a-881a053514cc	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Macleods Pharmaceuticals Limited	850566b1-0c8e-42bc-85fa-c8ee710f34ba	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	734beeef-3968-4137-af2c-276e8a9317df	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	e99e1446-9c85-478c-9e23-a5f4104bbd22	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Safecor Health LLC	fc02db0f-5311-4b61-896e-bfe340832735	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	fb1606ea-1cff-46fd-b8e5-8135da76436c	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	106b33e3-b199-e555-e063-6294a90a5af5	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	09a5d332-347b-e73d-e063-6294a90a67ed	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	f29febd6-5a27-eb83-e053-2a95a90a5b7d	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	090aa3a9-910e-4f96-b748-783109aa96e6	2025-12-12	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Cardizem CD	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	1042fa13-e6af-46b9-8008-6c941f0978b1	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Limited	74bab197-f719-48c0-ac84-c0cf0087b45a	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ab38794a-914d-4bcd-9c6d-1578aa10041a	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	3a620125-898a-47ba-9000-4295c3a3ad72	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	American Health Packaging	14869f9e-6a66-4f75-b0fc-4d808b1ee85e	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Cardizem LA	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	3e180dc7-c871-4efc-8755-cae882976c8d	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1913	SUPPL	2004-12-30