Application 019471

Type: NDA
Sponsor: BIOVAIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019471-001	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23
N019471-002	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23
N019471-003	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23
N019471-004	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019471-001	CARDIZEM SR	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019471-002	CARDIZEM SR	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019471-003	CARDIZEM SR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019471-004	CARDIZEM SR	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1989-01-23	`5bbf6a4d5a75…`

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 6 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	762c3007-b22f-4d35-87b4-191fec8b3a9a	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	eebf29fe-ce22-4482-b850-5854550bf2c4	2023-08-04	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	225a87fb-d353-4ee7-bd08-14d631ff6b16	2023-06-07	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f69371d-3ede-285d-e053-2a95a90a6e42	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Proficient Rx LP	a24255a3-88b1-47ef-90fc-51619a1c5a63	2023-05-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	5460158f-7782-45f4-89b1-f84e6ba178d8	2023-01-17	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	6f71ba5e-7bd6-409a-80c6-2f22d975aefc	2023-01-09	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	f6a24de7-8ffe-48af-873f-10fdcd5551d1	2020-06-02	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	609e97e5-ebc7-4268-84ea-f279284c89e2	2020-01-19	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.