Application 078538

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078538-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		2008-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078538-001	AP

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078538-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078538-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078538-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078538-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078538-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078538-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078538-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078538-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078538-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078538-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078538-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078538-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078538-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078538-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078538-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078538-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078538-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078538-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078538-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078538-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078538-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078538-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078538-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078538-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078538-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078538-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078538-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078538-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078538-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078538-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078538-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078538-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078538-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078538-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078538-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078538-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078538-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078538-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078538-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078538-001	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	734beeef-3968-4137-af2c-276e8a9317df	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538 ndc (product): 0641-9217 ndc (product): 0641-9218 ndc (product): 0641-9219
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	453b73bd-c52d-4d72-a0b3-47588e723e0b	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538 ndc (product): 0641-6014 ndc (product): 0641-6013 ndc (product): 0641-6015
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f69371d-3ede-285d-e053-2a95a90a6e42	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538 ndc (product): 71872-7063
DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	7d8e8b1e-f67b-57d2-e053-2991aa0a8d12	2023-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538 ndc (product): 51662-1335

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6013	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6013	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6014	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6014	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6015	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6015	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-9217	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-9217	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-9218	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-9218	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-9219	Diltiazem Hydrochloride	Diltiazem Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-9219	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1335	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1335	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1335	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1335	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
71872-7063	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current