Orange Book product · Brand (NDA)
RENOVA
TRETINOIN
At a glance
Dec 29, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 29, 1995
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TRETINOIN
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019963
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.
- 2018ALTRENOBrand (NDA)
NDA 209353 · DOW PHARM
- 2007ATRALINBrand (NDA)
NDA 022070 · DOW PHARM
- 2002RETIN-A MICROBrand (NDA)
NDA 020475 · BAUSCH
- 2000RENOVABrand (NDA)
NDA 021108 · VALEANT PHARMS NORTH
- 1998AVITABrand (NDA)
NDA 020400 · RISING
- 1997AVITABrand (NDA)
NDA 020404 · MYLAN PHARMS INC
- 1995VESANOIDBrand (NDA)
NDA 020438 · CHEPLAPHARM
- 1988RETIN-ABrand (NDA)
NDA 019049 · BAUSCH
- —RETIN-ABrand (NDA)
NDA 017522 · VALEANT BERMUDA
- —RETIN-ABrand (NDA)
NDA 017340 · VALEANT PHARMS NORTH
- —RETIN-ABrand (NDA)
NDA 017955 · BAUSCH
- —RETIN-ABrand (NDA)
NDA 017579 · VALEANT INTL
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.
