Application 208191

Type: ANDA
Sponsor: DR REDDYS

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
A208191-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26
A208191-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26
A208191-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208191-001	AB
A208191-002	AB
A208191-003	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	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2016-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2016-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208191-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2016-08-26	`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	A208191-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208191-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208191-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208191-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208191-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208191-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208191-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208191-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208191-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208191-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208191-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208191-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208191-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208191-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208191-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208191-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208191-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208191-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208191-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208191-001	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	Golden State Medical Supply, Inc.	df52ab34-e44c-46f3-8c44-2c1bcb93f28e	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 60429-839 ndc (product): 60429-840 ndc (product): 60429-841
Nitroglycerin	NITROGLYCERIN	Dr. Reddys Laboratories Inc	c555f8de-477f-0225-98a2-baf8945bbd63	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 43598-437 ndc (product): 43598-435 ndc (product): 43598-436
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	c20e89b4-57b5-259d-e053-2a95a90a0038	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 51662-1282
Nitroglycerin	NITROGLYCERIN	A-S Medication Solutions	fc297c0a-a412-40be-8414-4bf9906fd300	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 50090-3266
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	6671d89f-cc89-c03c-e053-2a91aa0aa5fa	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 71872-7010
Nitroglycerin	NITROGLYCERIN	Proficient Rx LP	67a15ee9-a6ae-4a60-8333-e06c608cfd71	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208191 application number: ANDA208191 ndc (product): 71205-225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-435	Nitroglycerin	Nitroglycerin	Dr. Reddys Laboratories Inc	ANDA	Current
43598-436	Nitroglycerin	Nitroglycerin	Dr. Reddys Laboratories Inc	ANDA	Current
43598-437	Nitroglycerin	Nitroglycerin	Dr. Reddys Laboratories Inc	ANDA	Current
50090-3266	Nitroglycerin	Nitroglycerin	A-S Medication Solutions	ANDA	Current
50090-3266	Nitroglycerin	Nitroglycerin	A-S Medication Solutions	ANDA	Current
50090-3266	Nitroglycerin	Nitroglycerin	A-S Medication Solutions	ANDA	Current
50090-3266	Nitroglycerin	Nitroglycerin	A-S Medication Solutions	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1282	NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
60429-839	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
60429-839	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
60429-840	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
60429-840	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
60429-841	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
60429-841	Nitroglycerin	Nitroglycerin	Golden State Medical Supply, Inc.	ANDA	Current
68071-1330	Nitroglycerin	Nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1330	Nitroglycerin	Nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1330	Nitroglycerin	Nitroglycerin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0545	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
70518-0545	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
70518-0545	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
70518-0545	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
70518-0545	Nitroglycerin	Nitroglycerin	REMEDYREPACK INC.	ANDA	Current
71205-225	Nitroglycerin	Nitroglycerin	Proficient Rx LP	ANDA	Current
71205-225	Nitroglycerin	Nitroglycerin	Proficient Rx LP	ANDA	Current
71205-225	Nitroglycerin	Nitroglycerin	Proficient Rx LP	ANDA	Current
71205-225	Nitroglycerin	Nitroglycerin	Proficient Rx LP	ANDA	Current
71872-7010	Nitroglycerin	Nitroglycerin	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7010	Nitroglycerin	Nitroglycerin	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45121	ORIG	2016-08-31