Orange Book product · Brand (NDA)
RETIN-A
TRETINOIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TRETINOIN
Strength
0.01%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 017955
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1995RENOVABrand (NDA)
NDA 019963 · VALEANT PHARMS NORTH
- 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 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.
