Orange Book product · Brand (NDA)
GONITRO
NITROGLYCERIN
At a glance
Jun 08, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 08, 2016
10 yr 2 mo ago
Today
Patent 9101592 expires
Listed drug product patent expiration.
Mar 11, 2032
in 5 yr 10 mo
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.4MG/PACKET
Dosage form
POWDER
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 208424
Product number
001
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.
- 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
- —NITROSTATBrand (NDA)
NDA 018588 · PARKE DAVIS
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9101592 | Mar 11, 2032 | in 5 yr 10 mo | Product |
