Orange Book product · Brand (NDA)
NITROSTAT
NITROGLYCERIN
At a glance
May 01, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2000
26 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.3MG
Dosage form
TABLET
Route
SUBLINGUAL
TE code
AB
Application
NDA 021134
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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.
