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 5 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	A-S Medication Solutions	88b150a6-4c8d-49c8-88df-f3606c335472	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	70f167a1-ec7f-4969-b446-166af3e52c05	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	74620be9-5120-491a-a171-e50612c06541	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Dr. Reddy's Labratories Inc.	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	2024-08-19	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	54b0b11d-adc0-4afb-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Chartwell RX, LLC	51abce7b-e3d1-44b5-bccc-d463150d0bba	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cdb473a-e6d5-48e8-e053-2a91aa0aaeb7	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	636556f6-2987-984f-e053-2991aa0a201a	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	fe7ca564-16b8-4c54-aa09-3e2ed0c2596a	2024-05-17	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	f317de31-495c-4268-8171-89534bf1dd36	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	453b73bd-c52d-4d72-a0b3-47588e723e0b	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	de2a0c48-7fc4-4760-b465-a79299876e6e	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	74232d69-1a8c-449d-8e8e-85488e6cc8f8	2024-04-03	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	6ca6a648-fc67-4cf8-a1f7-787c9574e3a1	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	0e9b4421-bc43-4a77-b49b-e3f53d1e0f01	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	a6cc3b99-2c0f-4d8a-8393-ec042ed7c892	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
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 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