Orange Book product · Brand (NDA)
RECTIV
NITROGLYCERIN
At a glance
Jun 21, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 21, 2011
15 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROGLYCERIN
Strength
0.4%
Dosage form
OINTMENT
Route
INTRA-ANAL
TE code
Not listed
Application
NDA 021359
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.
- 2016GONITROBrand (NDA)
NDA 208424 · POHL BOSKAMP
- 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
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.
