Orange Book product · Generic (ANDA)
NITROGLYCERIN
NITROGLYCERIN
At a glance
Dec 18, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2025
6 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.4%
Dosage form
OINTMENT
Route
INTRA-ANAL
TE code
AB
Application
ANDA 218756
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NITROGLYCERIN
- 2016GONITROBrand (NDA)
NDA 208424 · POHL BOSKAMP
- 2011RECTIVBrand (NDA)
NDA 021359 · ABBVIE
- 2006NITROMISTBrand (NDA)
NDA 021780 · EVUS
- 1996TRANSDERM-NITROBrand (NDA)
NDA 020144 · NOVARTIS
- 1995NITRO-DURBrand (NDA)
NDA 020145 · USPHARMA
- 1989NITROGLYCERIN IN DEXTROSE 5%Brand (NDA)
NDA 019970 · BAXTER HLTHCARE
- 1985NITROLINGUALBrand (NDA)
NDA 018705 · POHL BOSKAMP
- 1983NITRO IVBrand (NDA)
NDA 018672 · POHL BOSKAMP
- 1983TRIDILBrand (NDA)
NDA 018537 · HOSPIRA
- 1983NITROLBrand (NDA)
NDA 018774 · RORER
- 1982NITRO-BIDBrand (NDA)
NDA 018621 · SANOFI AVENTIS US
- —NITROGLYCERINBrand (NDA)
NDA 018531 · HOSPIRA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
