Application 207745

Type: ANDA
Sponsor: SIGMAPHARM LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGLYCERIN	NITROGLYCERIN	TABLET;SUBLINGUAL	0.3MG	No	No
002	NITROGLYCERIN	NITROGLYCERIN	TABLET;SUBLINGUAL	0.4MG	No	No
003	NITROGLYCERIN	NITROGLYCERIN	TABLET;SUBLINGUAL	0.6MG	No	No

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

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	Approval date
A207745-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07
A207745-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07
A207745-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207745-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207745-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207745-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207745-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207745-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207745-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207745-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207745-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207745-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207745-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207745-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207745-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207745-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207745-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207745-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207745-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207745-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207745-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207745-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207745-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207745-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207745-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207745-003	AB	1	`ea99ee380514…`

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 3 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROLINGUAL	NITROGLYCERIN	INDEPENDENCE PHARMACEUTICALS, LLC	d19b5f51-ca85-48d6-9ccd-8ae26249cdc3	2024-05-13	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Cosette Pharmaceuticals, Inc.	ac908e70-9425-4e9c-8c67-7b2882b40204	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Proficient Rx LP	160b85ac-d964-463b-9f1e-1429f14ed318	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Prasco Laboratories	f9731c86-34b0-42a2-8b39-eca907e02e74	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	A-S Medication Solutions	fc297c0a-a412-40be-8414-4bf9906fd300	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a1163a-fe45-e31a-e053-2991aa0a6466	2023-11-13		Name fallback generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a39d5c-2b11-62ed-e053-2a91aa0a0a31	2023-11-13		Name fallback generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a33a5a-41c6-3d84-e053-2a91aa0a6ec7	2023-11-13		Name fallback generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	7c0efc90-7a53-11e6-a302-424c58303031	2023-11-13		Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Aurobindo Pharma Limited	26c314ea-077e-490b-826b-2aafcb6e9564	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a47cfa-4d34-a596-e053-2a91aa0a02dc	2023-10-30		Name fallback generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a3b808-b45a-f2f0-e053-2a91aa0af21f	2023-10-23		Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Natco Pharma USA LLC	941ac242-120e-47c1-ac03-50026ff93dd6	2023-07-20	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	6671d89f-cc89-c03c-e053-2a91aa0aa5fa	2023-06-05	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	8959095a-8cd8-f7d4-e053-2995a90a6e8f	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
NITRO-DUR	NITROGLYCERIN	Ingenus Pharmaceuticals, LLC	5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0	2023-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Medical Purchasing Solutions, LL	f9b52553-5a26-d374-e053-6294a90a40c7	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a3f76b-7b09-5d00-e053-2a91aa0ad1de	2023-02-20		Name fallback generic name: NITROGLYCERIN
Nitrostat	NITROGLYCERIN	Viatris Specialty LLC	9a52da75-d0af-4237-96c0-0b12adfa8636	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Glonoinum	NITROGLYCERIN	Boiron	85a39643-ae56-f21e-e053-2991aa0a4915	2023-01-23		Name fallback generic name: NITROGLYCERIN

Reported adverse events (FAERS/openFDA)#

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