Orange Book product · Brand (NDA)
TRANSDERM-NITRO
NITROGLYCERIN
At a glance
Feb 27, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 1996
30 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 020144
Product number
005
Marketing status
DISCN
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
- 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
- —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.
