Application 076395

Type: ANDA
Sponsor: APOTEX INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076395-001	DILTZAC	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01
A076395-002	DILTZAC	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01
A076395-003	DILTZAC	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01
A076395-004	DILTZAC	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01
A076395-005	DILTZAC	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076395-001	DILTZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076395-002	DILTZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076395-003	DILTZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076395-004	DILTZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076395-005	DILTZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2006-02-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076395-001	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076395-002	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076395-003	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076395-004	AB4	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076395-005	AB4	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076395-001	AB4	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076395-002	AB4	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076395-003	AB4	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076395-004	AB4	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076395-005	AB4	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076395-001	AB4	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076395-002	AB4	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076395-003	AB4	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076395-004	AB4	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076395-005	AB4	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076395-001	AB4	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076395-002	AB4	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076395-003	AB4	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076395-004	AB4	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076395-005	AB4	1	`ea99ee380514…`

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 3 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	58eeb8bc-91d0-4cf8-a0d7-be3548d92196	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Eugia US LLC	f8d962ab-6cd4-43a1-a8fa-fb6548ac2a08	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	41d75325-d935-ba54-e063-6394a90aade2	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	22e653e5-4122-4d7d-b9ad-0bdc1390fb40	2025-10-20	Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	1ca03c9e-edc8-4c7f-89ee-f2346ea8c067	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc	196fc367-330e-4d15-b1d6-084ad3f97ae7	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	862d65cb-a732-4786-b569-bad2eaafddfd	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Accord Healthcare, Inc.	70293a05-d314-43fa-a2b1-398cfb39edf8	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c8809dc9-b99b-4d30-a7da-0bc21aa90f9c	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ProPharma Distribution	3f2942d7-f4d0-2d77-e063-6294a90a74ad	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c1ef9e90-6ff0-4ee5-86a3-1efee9c36789	2025-09-16	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ac9aa10d-cd52-4ac9-a01d-e3cbf14d4913	2025-08-30	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e6d9397c-f8a2-42d6-88ca-55060b1d073a	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	9041cc05-29d2-41ca-a368-e953bf3443b5	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	0089fc7a-a7aa-4873-b699-39a1b21616ca	2025-08-20	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Cipla USA, Inc.	bce61158-201d-458c-be0c-9bdd2d3a0bec	2025-08-01	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	OCEANSIDE PHARMACEUTICALS	43892b97-449d-45bc-bb09-29d47c655d65	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Institutional Inc.	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	2025-07-18	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.