Is there a generic for Nitroglycerin?

Yes. The FDA Orange Book lists 43 approved generic (ANDA) applications for Nitroglycerin, referencing the brand GONITRO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nitroglycerin?

GONITRO (NDA 208424, POHL BOSKAMP) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Nitroglycerin?

The Orange Book lists 2 patents against Nitroglycerin products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Nitroglycerin are approved?

Nitroglycerin is approved in the following dosage forms: aerosol, aerosol, metered, film, extended release, injectable, ointment, powder, spray, metered, tablet.

FDA Orange Book · active-ingredient family

Nitroglycerin

Nitroglycerin: 14 brands, 43 generics; first approved Jan 05, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 43 ANDA applications approved.

Earliest patent expiry Mar 12, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 12, 2029

in 2 yr 8 mo

Brand (NDA) products

Originator applications

GONITRORLD
POHL BOSKAMPNDA 2084242016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/PACKET POWDER SUBLINGUAL Discontinued —
RECTIVRLD
ABBVIENDA 0213592011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Discontinued —
NITROMISTRLDRS
EVUSNDA 0217802006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/SPRAY AEROSOL, METERED SUBLINGUAL Rx —
NITROSTATRLD
VIATRISNDA 02113420003 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROLINGUAL PUMPSPRAYRLDRS
POHL BOSKAMPNDA 01870519972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/SPRAY AEROSOL SUBLINGUAL Discontinued —
0.4MG/SPRAY SPRAY, METERED SUBLINGUAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/PACKET	POWDER	SUBLINGUAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/SPRAY	AEROSOL, METERED	SUBLINGUAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/SPRAY	AEROSOL	SUBLINGUAL	Discontinued	—
0.4MG/SPRAY	SPRAY, METERED	SUBLINGUAL	Rx	AB

TRANSDERM-NITRORLD

NOVARTISNDA 02014419965 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.6MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.8MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

NITRO-DURRLD

USPHARMANDA 02014519956 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—
0.3MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—
0.6MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—
0.8MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	—

NITROGLYCERIN IN DEXTROSE 5%RLDRS
BAXTER HLTHCARENDA 01997019893 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/100ML INJECTABLE INJECTION Rx —
20MG/100ML INJECTABLE INJECTION Rx —
40MG/100ML INJECTABLE INJECTION Rx —
NITROGLYCERINRLD
HOSPIRANDA 018531—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITRO IV
POHL BOSKAMPNDA 01867219832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
5MG/ML INJECTABLE INJECTION Discontinued —
TRIDIL
HOSPIRANDA 01853719832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
0.5MG/ML INJECTABLE INJECTION Discontinued —
NITROL
RORERNDA 0187741983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.8MG/ML INJECTABLE INJECTION Discontinued —
NITRO-BID
SANOFI AVENTIS USNDA 0186211982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROSTAT
PARKE DAVISNDA 018588—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.8MG/ML INJECTABLE INJECTION Discontinued —
5MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/100ML	INJECTABLE	INJECTION	Rx	—
20MG/100ML	INJECTABLE	INJECTION	Rx	—
40MG/100ML	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.8MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.8MG/ML	INJECTABLE	INJECTION	Discontinued	—
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (43)

Abbreviated applications

NITROGLYCERIN
PADAGIS ISRAELANDA 2145652026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Rx AB
NITROGLYCERIN
SOLARIS PHARMA CORPANDA 2187562025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Rx AB
NITROGLYCERIN
ENCUBEANDA 2182352025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% OINTMENT TRANSDERMAL Rx AB
NITROGLYCERIN
ENCUBEANDA 2164522024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Rx AB
NITROGLYCERIN
TP ANDA HOLDINGSANDA 2122222024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Rx AB
NITROGLYCERIN
VIWIT PHARMANDA 21858320243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERINRS
COSETTE PHARMS NCANDA 2161032024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4% OINTMENT INTRA-ANAL Rx AB
NITROGLYCERIN
MANKIND PHARMAANDA 21797020233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
AUROBINDO PHARMAANDA 21787920233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
ZYDUS PHARMSANDA 21015320223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Discontinued —
0.4MG TABLET SUBLINGUAL Discontinued —
0.6MG TABLET SUBLINGUAL Discontinued —
NITROGLYCERIN
RUBICON RESEARCHANDA 20977920213 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
NATCOANDA 21160420193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
SIGMAPHARM LABS LLCANDA 20774520183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Discontinued —
0.4MG TABLET SUBLINGUAL Discontinued —
0.6MG TABLET SUBLINGUAL Discontinued —
NITROGLYCERIN
ZYDUS PHARMSANDA 08988520172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB2
0.1MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB2
NITROGLYCERIN
ACTAVIS LABS FL INCANDA 20369320173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Discontinued —
0.4MG TABLET SUBLINGUAL Discontinued —
0.6MG TABLET SUBLINGUAL Discontinued —
NITROGLYCERIN
GLENMARK SPECLTANDA 20639120173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
DR REDDYSANDA 20819120163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET SUBLINGUAL Rx AB
0.4MG TABLET SUBLINGUAL Rx AB
0.6MG TABLET SUBLINGUAL Rx AB
NITROGLYCERIN
PADAGIS ISRAELANDA 0914962013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/SPRAY SPRAY, METERED SUBLINGUAL Rx AB
NITROGLYCERIN
LANNETT CO INCANDA 07511520042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
0.4MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	OINTMENT	TRANSDERMAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4%	OINTMENT	INTRA-ANAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Discontinued	—
0.4MG	TABLET	SUBLINGUAL	Discontinued	—
0.6MG	TABLET	SUBLINGUAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Discontinued	—
0.4MG	TABLET	SUBLINGUAL	Discontinued	—
0.6MG	TABLET	SUBLINGUAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.1MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Discontinued	—
0.4MG	TABLET	SUBLINGUAL	Discontinued	—
0.6MG	TABLET	SUBLINGUAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	SUBLINGUAL	Rx	AB
0.4MG	TABLET	SUBLINGUAL	Rx	AB
0.6MG	TABLET	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/SPRAY	SPRAY, METERED	SUBLINGUAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

NITROGLYCERIN

MYLAN TECHNOLOGIESANDA 07499219994 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.1MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

NITROGLYCERIN
ZYDUS PHARMSANDA 0898841998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB2
NITROGLYCERIN
ZYDUS PHARMSANDA 0898861998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB2

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

NITROGLYCERIN

MYLAN TECHNOLOGIESANDA 07455919984 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.1MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

MINITRAN
BAUSCHANDA 0897731996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
MINITRAN
VALEANT PHARMSANDA 0897711996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
MINITRAN
VALEANT PHARMSANDA 0897741996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
MINITRAN
VALEANT PHARMS NORTHANDA 0897721996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG/HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRAANDA 0740831994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRAANDA 0718461990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/100ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRAANDA 0718471990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG/100ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRAANDA 0718481990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/100ML INJECTABLE INJECTION Discontinued —
NITRO-BID
SANOFI AVENTIS USANDA 0711591990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERINRLDRS
FOUGERA PHARMS INCANDA 0873551988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% OINTMENT TRANSDERMAL Rx AB
NITROGLYCERINRS
AM REGENTANDA 0720341988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Rx —
NITROGLYCERIN
LUITPOLDANDA 0714921988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN
ABRAXIS PHARMANDA 0712031987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROSTAT
PARKE DAVISANDA 0708631987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROSTAT
PARKE DAVISANDA 0708711987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
NITROSTAT
PARKE DAVISANDA 0708721987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN
SMITH AND NEPHEWANDA 0706331986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN
SMITH AND NEPHEWANDA 0706341986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN
ABRAXIS PHARMANDA 0700771985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
NITROGLYCERIN
INTL MEDICATIONANDA 0700261985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	OINTMENT	TRANSDERMAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7872049	Mar 12, 2029	in 2 yr 8 mo	ProductU-2223
9101592	Mar 11, 2032	in 5 yr 8 mo	Product

Approval history

FDA approval span

First approval

Jan 05, 1982

45 yr 3 mo ago

Most recent approval

Jul 06, 2026

29 d ago

Approvals span 1982–2026 across 57 FDA applications.

Brand (NDA) 1425%

Generic (ANDA) 4375%

Nitroglycerin: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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