Application 020144

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANSDERM-NITRO	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	TRANSDERM-NITRO	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	TRANSDERM-NITRO	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	TRANSDERM-NITRO	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	TRANSDERM-NITRO	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020144-001	TRANSDERM-NITRO	NITROGLYCERIN	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27
N020144-002	TRANSDERM-NITRO	NITROGLYCERIN	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27
N020144-003	TRANSDERM-NITRO	NITROGLYCERIN	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27
N020144-004	TRANSDERM-NITRO	NITROGLYCERIN	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27
N020144-005	TRANSDERM-NITRO	NITROGLYCERIN	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020144-001	TRANSDERM-NITRO	0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020144-002	TRANSDERM-NITRO	0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020144-003	TRANSDERM-NITRO	0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020144-004	TRANSDERM-NITRO	0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020144-005	TRANSDERM-NITRO	0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-02-27	`03ed91905a0d…`

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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	2022-12-09	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
nitroglycerin lingual	NITROGLYCERIN	Padagis Israel Pharmaceuticals Ltd	e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Proficient Rx LP	67a15ee9-a6ae-4a60-8333-e06c608cfd71	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	American Regent, Inc.	8c52cdf6-87be-4719-b105-f08be096d462	2021-07-22	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin Transdermal Infusion System	NITROGLYCERIN	Dr. Reddy's Laboratories, Inc.	4f85d2e0-2e37-fcd1-276d-5a6466554289	2020-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitrostat	NITROGLYCERIN	Proficient Rx LP	6fe3965f-0dd8-4bae-9771-de25074cb1b0	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin In Dextrose	NITROGLYCERIN	Baxter Healthcare Company	457a026c-ebce-4701-9deb-2d7652759a99	2016-08-22	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	e98a2692-1cb9-4994-98d8-1d8d9ef1a256	2014-11-03	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN

Reported adverse events (FAERS/openFDA)#

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