Application 211604

Type: ANDA
Sponsor: ALVOGEN

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	TE codes	Approval date
A211604-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30
A211604-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30
A211604-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211604-001	AB
A211604-002	AB
A211604-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A211604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211604-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGLYCERIN	NITROGLYCERIN	Sportpharm LLC	84739085-81df-4a43-8456-c9edfbf971e9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Redpharm Drug	3dd022d8-c224-d19f-e063-6394a90adca4	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	NuCare Pharmaceuticals,Inc.	f4ea9ad1-a71f-7cea-e053-2a95a90a106d	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Proficient Rx LP	160b85ac-d964-463b-9f1e-1429f14ed318	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Natco Pharma USA LLC	941ac242-120e-47c1-ac03-50026ff93dd6	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604 ndc (product): 69339-175 ndc (product): 69339-174 ndc (product): 69339-173
NITROGLYCERIN	NITROGLYCERIN	Medical Purchasing Solutions, LL	f9b52553-5a26-d374-e053-6294a90a40c7	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-456	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-456	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-456	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-456	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-457	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-457	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-457	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-457	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-458	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-458	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-458	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
47781-458	nitroglycerin	nitroglycerin	Alvogen Inc.	ANDA	Current
50090-4874	nitroglycerin	nitroglycerin	A-S Medication Solutions	ANDA	Current
50090-4874	nitroglycerin	nitroglycerin	A-S Medication Solutions	ANDA	Current
50090-4874	nitroglycerin	nitroglycerin	A-S Medication Solutions	ANDA	Current
63629-8828	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
63629-8828	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
63629-8829	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
63629-8829	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
63629-8830	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
63629-8830	nitroglycerin	nitroglycerin	Bryant Ranch Prepack	ANDA	Current
68071-2260	nitroglycerin	nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2260	nitroglycerin	nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
69339-173	NITROGLYCERIN	NITROGLYCERIN	DASH Pharmaceuticals LLC	ANDA	Current
69339-174	NITROGLYCERIN	NITROGLYCERIN	DASH Pharmaceuticals LLC	ANDA	Current
69339-175	NITROGLYCERIN	NITROGLYCERIN	DASH Pharmaceuticals LLC	ANDA	Current
71205-482	nitroglycerin	nitroglycerin	Proficient Rx LP	ANDA	Current
71205-482	nitroglycerin	nitroglycerin	Proficient Rx LP	ANDA	Current
71872-7201	nitroglycerin	nitroglycerin	Medical Purchasing Solutions, LLC	ANDA	Current