Application 018588

Type: NDA
Sponsor: PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROSTAT	NITROGLYCERIN	INJECTABLE;INJECTION	0.8MG/ML	No	No
002	NITROSTAT	NITROGLYCERIN	INJECTABLE;INJECTION	5MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018588-001	NITROSTAT	NITROGLYCERIN	0.8MG/ML	INJECTABLE / INJECTION		Approved before 1982
N018588-002	NITROSTAT	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION			1983-12-23

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018588-001	NITROSTAT	0.8MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018588-002	NITROSTAT	5MG/ML	INJECTABLE / INJECTION		1983-12-23	`3a93d1ddd44b…`

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC.	5b150cd2-fac8-86ce-e063-6294a90a67b9	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Rectiv	NITROGLYCERIN	Allergan, Inc.	603aa9ed-54c4-4a35-ade4-690fa44850e4	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	89da40c1-bab1-422e-b326-8ebcbdbc81f3	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	b8af0974-33ea-4dd5-9ff7-3b61272aeb25	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	9a539019-5f43-1448-e053-2a95a90a3bca	2026-08-25	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
nitroglycerin	NITROGLYCERIN	Redpharm Drug	594b939f-d399-835e-e063-6294a90a4422	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	486f53ce-e3c6-48b0-a6ef-9d08cde387e3	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Padagis Israel Pharmaceuticals Ltd	562d2e03-dfed-41ff-8e7f-ec4169141983	2026-07-06	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Encube Ethicals, Inc.	c17c997b-0e90-4105-888b-2de22d2bf697	2026-05-28	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITRO-TIME	NITROGLYCERIN	TIME CAP LABORATORIES, INC	3c11c1c2-8e62-4f63-8293-2f8b8d845f7e	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Bryant Ranch Prepack	7cf08521-aaf6-4129-9f8e-077d6282fbc6	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Sportpharm LLC	84739085-81df-4a43-8456-c9edfbf971e9	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	4e83a438-1ed6-0a86-e063-6294a90adc8c	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	4b4667e9-3b5e-4dc0-e063-6394a90ac1f5	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Golden State Medical Supply, Inc.	df52ab34-e44c-46f3-8c44-2c1bcb93f28e	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	A-S Medication Solutions	532e30c4-cbda-4450-b0a0-e08601c202fb	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITRO-BID	NITROGLYCERIN	Savage Laboratories a division of Fougera Pharmaceuticals, LLC	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Dr. Reddys Laboratories Inc	c555f8de-477f-0225-98a2-baf8945bbd63	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Advagen Pharma Ltd	5a36dac2-7d35-4cbf-be3d-705b7135754d	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Glenmark Pharmaceuticals Inc., USA	fa789d65-9407-4965-bd06-4457444b42be	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN

Reported adverse events (FAERS/openFDA)#

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