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 2 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	Alembic Pharmaceuticals Inc.	04a85be5-f746-418e-8e37-292703f16934	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Cardinal Health 107, LLC	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	REMEDYREPACK INC.	5e935265-d0fc-4223-835f-72426eeea6c4	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3d594530-885f-45c7-b8a5-fd7e503ff83f	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
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	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

Reported adverse events (FAERS/openFDA)#

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