Application 018705

Type: NDA
Sponsor: POHL BOSKAMP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROLINGUAL	NITROGLYCERIN	AEROSOL;SUBLINGUAL	0.4MG/SPRAY	No	No
002	NITROLINGUAL PUMPSPRAY	NITROGLYCERIN	SPRAY, METERED;SUBLINGUAL	0.4MG/SPRAY	Yes	Yes

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

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
N018705-001	NITROLINGUAL	NITROGLYCERIN	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31
N018705-002	NITROLINGUAL PUMPSPRAY	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018705-002	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-001	NITROLINGUAL	0.4MG/SPRAY	AEROSOL / SUBLINGUAL			1985-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018705-002	NITROLINGUAL PUMPSPRAY	0.4MG/SPRAY	SPRAY, METERED / SUBLINGUAL	AB	RLD, RS	1997-01-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018705-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018705-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018705-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018705-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018705-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018705-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018705-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018705-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018705-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018705-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018705-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018705-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018705-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018705-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018705-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018705-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018705-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018705-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018705-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018705-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018705-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018705-002	7872049	2029-03-12	U-2223	Drug product	2012-04-11	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN LINGUAL	NITROGLYCERIN	Allegis Pharmaceuticals, LLC	fadd07b7-189b-4678-ad0f-bf1e4d3d1300	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705 ndc (product): 28595-120
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	422b4713-9531-f1bf-e063-6294a90ada2b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
NITROLINGUAL	NITROGLYCERIN	INDEPENDENCE PHARMACEUTICALS, LLC	d19b5f51-ca85-48d6-9ccd-8ae26249cdc3	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705
NITROGLYCERIN LINGUAL	NITROGLYCERIN LINGUAL	HF Acquisition Co LLC, DBA HealthFirst	a8eb91f6-7f2e-7d57-e053-2995a90a3893	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705 ndc (product): 51662-1519
Nitroglycerin	NITROGLYCERIN	Prasco Laboratories	f9731c86-34b0-42a2-8b39-eca907e02e74	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018705 application number: NDA018705

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
28595-120	NITROGLYCERIN LINGUAL	Nitroglycerin	Allegis Pharmaceuticals, LLC	NDA	Current
28595-550	NITROLINGUAL	Nitroglycerin	Allegis Pharmaceuticals, LLC	NDA	Current
51662-1244	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1244	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1244	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1244	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1351	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1351	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1351	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1351	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1519	NITROGLYCERIN LINGUAL	NITROGLYCERIN LINGUAL	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
70003-300	NITROGLYCERIN LINGUAL	Nitroglycerin	Jacksonville Pharmaceuticals, Inc.	NDA	Current
70003-300	NITROGLYCERIN LINGUAL	Nitroglycerin	Jacksonville Pharmaceuticals, Inc.	NDA	Current
70007-300	NITROLINGUAL	Nitroglycerin	Espero Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55078	SUPPL	2018-08-02
55058	SUPPL	2018-07-30
33566	SUPPL	2015-01-30
15106	SUPPL	2015-01-26
11288	SUPPL	2008-10-09
15105	SUPPL	2008-10-06
1041	SUPPL	2006-10-02
1040	SUPPL	2006-02-22
1039	SUPPL	2004-09-03
1038	SUPPL	2002-11-05