Application 074559

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.6MG/HR	No	Yes
002	NITROGLYCERIN	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.4MG/HR	No	Yes
003	NITROGLYCERIN	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/HR	No	Yes
004	NITROGLYCERIN	NITROGLYCERIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/HR	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074559-001	NITROGLYCERIN	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1996-08-30
A074559-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30
A074559-003	NITROGLYCERIN	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1996-08-30
A074559-004	NITROGLYCERIN	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1998-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074559-001	AB2
A074559-002	AB2
A074559-003	AB2
A074559-004	AB2

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1996-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1996-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2		1998-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074559-001	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-002	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-003	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1996-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-004	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RS	1998-02-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074559-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074559-004	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074559-004	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074559-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074559-004	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074559-004	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074559-004	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074559-004	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074559-004	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-003	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074559-004	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-003	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074559-004	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074559-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-003	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074559-004	AB2	1	`d06236e962d9…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitroglycerin	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	e98a2692-1cb9-4994-98d8-1d8d9ef1a256	2014-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074559 application number: ANDA074559 ndc (product): 0378-9104 ndc (product): 0378-9116 ndc (product): 0378-9112 ndc (product): 0378-9102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-9102	Nitroglycerin	nitroglycerin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9104	Nitroglycerin	nitroglycerin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9112	Nitroglycerin	nitroglycerin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9116	Nitroglycerin	nitroglycerin	Mylan Pharmaceuticals Inc.	ANDA	Current