Application 206391

Type: ANDA
Sponsor: GLENMARK PHARMS SA

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
A206391-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19
A206391-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19
A206391-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206391-001	AB
A206391-002	AB
A206391-003	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	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`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	A206391-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206391-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206391-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206391-001	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	A-S Medication Solutions	532e30c4-cbda-4450-b0a0-e08601c202fb	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Glenmark Pharmaceuticals Inc., USA	fa789d65-9407-4965-bd06-4457444b42be	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391 ndc (product): 68462-638 ndc (product): 68462-640 ndc (product): 68462-639
Nitroglycerin	NITROGLYCERIN	ProPharma Distribution	3d71f76d-bb22-7251-e063-6394a90aa9d8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	NuCare Pharmaceuticals, Inc.	2bad7976-4eb0-d064-e063-6394a90a75de	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Proficient Rx LP	41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	8959095a-8cd8-f7d4-e053-2995a90a6e8f	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391 ndc (product): 71872-7033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-4343	Nitroglycerin	Nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-638	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-638	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-639	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-639	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-640	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-640	Nitroglycerin	Nitroglycerin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-2910	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
71872-7033	Nitroglycerin	Nitroglycerin	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49843	ORIG	2017-09-22