Application 019970

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	10MG/100ML	Yes	Yes
002	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	20MG/100ML	Yes	Yes
003	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	INJECTABLE;INJECTION	40MG/100ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019970-001	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29
N019970-002	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29
N019970-003	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29

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 4 · 126 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	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

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	N019970-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019970-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019970-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019970-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019970-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019970-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019970-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019970-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019970-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019970-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019970-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019970-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019970-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019970-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019970-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019970-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019970-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019970-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019970-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019970-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019970-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019970-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019970-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019970-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019970-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019970-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019970-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019970-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019970-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019970-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019970-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019970-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019970-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019970-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019970-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019970-003	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N019970-001	AP	1	`053a50430f4f…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitroglycerin In Dextrose	NITROGLYCERIN	ProPharma Distribution	3f2c9570-a544-1982-e063-6294a90a3067	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970
NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	7b98d1fc-44b2-08a1-e053-2991aa0af3ab	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970 ndc (product): 51662-1332
Nitroglycerin In Dextrose	NITROGLYCERIN	Baxter Healthcare Company	457a026c-ebce-4701-9deb-2d7652759a99	2016-08-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970 ndc (product): 0338-1049 ndc (product): 0338-1047 ndc (product): 0338-1051

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin	Baxter Healthcare Company	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1332	NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45109	SUPPL	2016-08-23
45155	SUPPL	2016-08-22
34169	SUPPL	2014-10-03
1879	SUPPL	2014-10-03