Application 072034

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN	NITROGLYCERIN	INJECTABLE;INJECTION	5MG/ML	No	Yes

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
A072034-001	NITROGLYCERIN	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION		RS	1988-05-24

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`e64feba35796…`

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
Nitroglycerin	NITROGLYCERIN	Henry Schein, Inc.	578d8159-5ec6-457f-b4a8-9add624d43a8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034 ndc (product): 0404-9928
Nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	b8af0974-33ea-4dd5-9ff7-3b61272aeb25	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	9453bd8b-5d54-5dc8-e053-2995a90a95b2	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034 ndc (product): 51662-1386
Nitroglycerin	NITROGLYCERIN	American Regent, Inc.	8c52cdf6-87be-4719-b105-f08be096d462	2021-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034 ndc (product): 0517-4810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9928	Nitroglycerin	Nitroglycerin	Henry Schein, Inc.	ANDA	Current
0404-9928	Nitroglycerin	Nitroglycerin	Henry Schein, Inc.	ANDA	Current
0517-4810	Nitroglycerin	nitroglycerin	American Regent, Inc.	ANDA	Current
0517-4810	Nitroglycerin	nitroglycerin	American Regent, Inc.	ANDA	Current
0517-4810	Nitroglycerin	nitroglycerin	American Regent, Inc.	ANDA	Current
51662-1386	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1386	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-810	Nitroglycerin	Nitroglycerin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-810	Nitroglycerin	Nitroglycerin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-810	Nitroglycerin	Nitroglycerin	General Injectables and Vaccines, Inc.	ANDA	Current
52584-810	Nitroglycerin	Nitroglycerin	General Injectables and Vaccines, Inc.	ANDA	Current