Application 021134

Type: NDA
Sponsor: PFIZER PHARMS

Application Products#

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

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	RLD / RS	Approval date
N021134-001	NITROSTAT	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01
N021134-002	NITROSTAT	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01
N021134-003	NITROSTAT	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021134-001	AB
N021134-002	AB
N021134-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-002	NITROSTAT	0.4MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-003	NITROSTAT	0.6MG	TABLET / SUBLINGUAL	AB	RLD, RS	2000-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021134-001	NITROSTAT	0.3MG	TABLET / SUBLINGUAL	AB	RLD	2000-05-01	`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	N021134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021134-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021134-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021134-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROSTAT	NITROGLYCERIN TABLET	Henry Schein, Inc.	5265648f-3062-48a2-a4e3-fea1207807a8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
NITROGLYCERIN	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	041f127e-5166-4484-bc1a-0a373d1187ae	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134 ndc (product): 59762-0489 ndc (product): 59762-4921 ndc (product): 59762-3304
NITROSTAT	NITROGLYCERIN	A-S Medication Solutions	f7059ff7-bf74-48b4-811d-6eb1c26bfd8b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
Nitrostat	NITROGLYCERIN	Viatris Specialty LLC	9a52da75-d0af-4237-96c0-0b12adfa8636	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134
Nitrostat	NITROGLYCERIN	Proficient Rx LP	6fe3965f-0dd8-4bae-9771-de25074cb1b0	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021134 application number: NDA021134 ndc (product): 63187-884

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-0417	Nitrostat	nitroglycerin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0418	Nitrostat	nitroglycerin	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0419	Nitrostat	nitroglycerin	Parke-Davis Div of Pfizer Inc	NDA	Current
0404-9929	NITROSTAT	nitroglycerin	Henry Schein, Inc.	NDA	Current
21695-450	Nitrostat	nitroglycerin	Rebel Distributors Corp	NDA	Current
50090-0133	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
50090-0133	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
50090-0332	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
50090-0332	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
50090-0332	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
50090-0332	Nitrostat	nitroglycerin	A-S Medication Solutions	NDA	Current
52584-418	NITROSTAT	nitroglycerin	General Injectables & Vaccines, Inc	NDA	Current
52584-418	NITROSTAT	nitroglycerin	General Injectables & Vaccines, Inc	NDA	Current
52584-418	NITROSTAT	nitroglycerin	General Injectables & Vaccines, Inc	NDA	Current
52584-418	NITROSTAT	nitroglycerin	General Injectables & Vaccines, Inc	NDA	Current
53217-066	Nitrostat	nitroglycerin	Aidarex Pharmaceuticals LLC	NDA	Current
55154-2433	Nitrostat	nitroglycerin	Cardinal Health	NDA	Current
59762-0489	NITROGLYCERIN	nitroglycerin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3304	NITROGLYCERIN	nitroglycerin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4921	NITROGLYCERIN	nitroglycerin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
63187-884	Nitrostat	nitroglycerin	Proficient Rx LP	NDA	Current
63187-884	Nitrostat	nitroglycerin	Proficient Rx LP	NDA	Current
68071-1720	Nitrostat	nitroglycerin	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1720	Nitrostat	nitroglycerin	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1720	Nitrostat	nitroglycerin	NuCare Pharmaceuticals,Inc.	NDA	Current
70385-2014	Nitrostat	nitroglycerin	Sina Health Inc	NDA	Current
70385-2018	NITROGLYCERIN	nitroglycerin	Sina Health Inc	NDA AUTHORIZED GENERIC	Current
70518-0105	Nitrostat	nitroglycerin	REMEDYREPACK INC.	NDA	Current
70518-0105	Nitrostat	nitroglycerin	REMEDYREPACK INC.	NDA	Current
70518-0105	Nitrostat	nitroglycerin	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
51910	SUPPL	2018-01-26
51907	SUPPL	2018-01-26
48386	SUPPL	2017-05-17
47071	SUPPL	2017-01-31
45163	SUPPL	2016-08-29
45162	SUPPL	2016-08-29
36196	SUPPL	2014-03-10
26874	SUPPL	2014-03-10
26873	SUPPL	2011-07-25
14473	SUPPL	2011-07-25
36195	SUPPL	2010-07-22
4435	SUPPL	2010-07-21
36194	ORIG	2000-05-01
21468	ORIG	2000-05-01
4434	ORIG	2000-05-01