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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207745-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	2018-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207745-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	2018-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207745-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	2018-05-07	`8072bd15b7f6…`

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 1 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN	NITROGLYCERIN	Padagis Israel Pharmaceuticals Ltd	562d2e03-dfed-41ff-8e7f-ec4169141983	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Encube Ethicals, Inc.	c17c997b-0e90-4105-888b-2de22d2bf697	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
NITRO-TIME	NITROGLYCERIN	TIME CAP LABORATORIES, INC	3c11c1c2-8e62-4f63-8293-2f8b8d845f7e	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Bryant Ranch Prepack	7cf08521-aaf6-4129-9f8e-077d6282fbc6	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	Sportpharm LLC	84739085-81df-4a43-8456-c9edfbf971e9	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	4e83a438-1ed6-0a86-e063-6294a90adc8c	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	4b4667e9-3b5e-4dc0-e063-6394a90ac1f5	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Golden State Medical Supply, Inc.	df52ab34-e44c-46f3-8c44-2c1bcb93f28e	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	A-S Medication Solutions	532e30c4-cbda-4450-b0a0-e08601c202fb	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
NITRO-BID	NITROGLYCERIN	Savage Laboratories a division of Fougera Pharmaceuticals, LLC	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Dr. Reddys Laboratories Inc	c555f8de-477f-0225-98a2-baf8945bbd63	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Advagen Pharma Ltd	5a36dac2-7d35-4cbf-be3d-705b7135754d	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Glenmark Pharmaceuticals Inc., USA	fa789d65-9407-4965-bd06-4457444b42be	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Solaris Pharma Corporation	f0a76edb-9e63-4aa4-9362-7375c799b2b5	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin In Dextrose	NITROGLYCERIN	ProPharma Distribution	3f2c9570-a544-1982-e063-6294a90a3067	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
NITROGLYCERIN LINGUAL	NITROGLYCERIN	Allegis Pharmaceuticals, LLC	fadd07b7-189b-4678-ad0f-bf1e4d3d1300	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	Henry Schein, Inc.	578d8159-5ec6-457f-b4a8-9add624d43a8	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	422b4713-9531-f1bf-e063-6294a90ada2b	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: NITROGLYCERIN generic name: NITROGLYCERIN
nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	89da40c1-bab1-422e-b326-8ebcbdbc81f3	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: nitroglycerin generic name: NITROGLYCERIN
Nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	b8af0974-33ea-4dd5-9ff7-3b61272aeb25	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Nitroglycerin generic name: NITROGLYCERIN