Orange Book product · Brand (NDA)
NITRO-DUR
NITROGLYCERIN
At a glance
Apr 04, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 04, 1995
31 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.8MG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 020145
Product number
006
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
- 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
- —NITROSTATBrand (NDA)
NDA 018588 · PARKE DAVIS
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.
