Application 218744

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A218744-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27
A218744-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27
A218744-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27
A218744-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27
A218744-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A218744-001	AB3
A218744-002	AB3
A218744-003	AB3
A218744-004	AB3
A218744-005	AB3

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A218744-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218744-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218744-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2026-02-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218744-001	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-002	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-003	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-004	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218744-005	AB3	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218744-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-004	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218744-005	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218744-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-004	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218744-005	AB3	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-001	AB3	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-002	AB3	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-003	AB3	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-004	AB3	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218744-005	AB3	1	`a50c72e98297…`

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 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Eugia US LLC	f8d962ab-6cd4-43a1-a8fa-fb6548ac2a08	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: DILTIAZEM HYDROCHLORIDE 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 brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	22e653e5-4122-4d7d-b9ad-0bdc1390fb40	2025-10-20	Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	1ca03c9e-edc8-4c7f-89ee-f2346ea8c067	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: DILTIAZEM HYDROCHLORIDE generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc	196fc367-330e-4d15-b1d6-084ad3f97ae7	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride 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 brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c8809dc9-b99b-4d30-a7da-0bc21aa90f9c	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ProPharma Distribution	3f2942d7-f4d0-2d77-e063-6294a90a74ad	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c1ef9e90-6ff0-4ee5-86a3-1efee9c36789	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ac9aa10d-cd52-4ac9-a01d-e3cbf14d4913	2025-08-30	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e6d9397c-f8a2-42d6-88ca-55060b1d073a	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	9041cc05-29d2-41ca-a368-e953bf3443b5	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	0089fc7a-a7aa-4873-b699-39a1b21616ca	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Cipla USA, Inc.	bce61158-201d-458c-be0c-9bdd2d3a0bec	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: DILTIAZEM HYDROCHLORIDE generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	OCEANSIDE PHARMACEUTICALS	43892b97-449d-45bc-bb09-29d47c655d65	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Institutional Inc.	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	355f560a-8ebb-4661-ad74-2a22f707d7f8	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	b4b4e53e-fc99-4f34-abc2-57e4f28aff84	2025-06-13	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c044f774-783f-4920-a8a1-6d4b1b3820c1	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85210	ORIG	2026-03-03