Application 202651

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	INJECTABLE; INJECTION	50MG/10ML	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	INJECTABLE; INJECTION	125MG/25ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202651-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION			2012-08-09

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 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION		2012-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202651-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2012-08-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202651-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202651-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202651-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202651-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202651-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202651-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202651-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202651-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202651-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202651-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202651-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202651-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202651-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202651-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202651-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202651-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202651-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202651-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202651-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202651-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202651-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202651-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202651-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202651-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202651-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202651-001	AP	1	`cb3db0bc1861…`

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 1 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	NORTHSTAR RX LLC	56616fc9-f3f7-8e0a-22c8-a6af106e6b1d	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: DILTIAZEM HYDROCHLORIDE generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	f7137458-0db3-7ecd-e053-6394a90a5f95	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	e66665e8-22eb-f5cd-e053-2a95a90a72e4	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	ec928ee5-0809-4ba5-82ca-ecfed99ebb5a	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Major Pharmaceuticals	e7476adc-a940-4e76-a1dd-c418de493bc0	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	fb6a6199-bb70-476e-a2a2-b7594c9c001a	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	American Health Packaging	11b43a17-8038-462b-8902-259431ad5256	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	465dbab3-f201-4441-8f55-92a843b5134f	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Golden State Medical Supply, Inc.	c9f17187-e958-106b-e053-2a95a90a54d8	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	50df9f09-aa2f-495d-a25c-7c5c0fdffcf0	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	bba03666-ff4f-4bf6-fa92-78e1ec2d9073	2026-05-24	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	76e04232-b3da-48e8-a944-5f4f97a508df	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	f276d9fe-a685-4d99-ad82-d4452ef4ba98	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northstar Rx LLC	e2511ffe-5821-4f64-a469-f8ef9618b1b5	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Zydus Lifesciences Limited	8329d0ac-d68c-48d2-9cbc-e1a1b60192d9	2026-05-01		Name fallback brand name: Diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Cartia XT	DILTIAZEM HYDROCHLORIDE	Actavis Pharma, Inc.	2dc2b889-8443-4f7f-83be-86c68e179804	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	04a85be5-f746-418e-8e37-292703f16934	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride 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 brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	REMEDYREPACK INC.	5e935265-d0fc-4223-835f-72426eeea6c4	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43409	ORIG	2013-02-26