Orange Book product · Brand (NDA)
XALATAN
LATANOPROST
At a glance
Jun 05, 1996
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 05, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LATANOPROST
Strength
0.005%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
NDA 020597
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.
- 2022IYUZEHBrand (NDA)
NDA 216472 · THEA PHARMA
- 2018XELPROSBrand (NDA)
NDA 206185 · SUN PHARM
- 2025LATANOPROSTGeneric (ANDA)
ANDA 220360 · MANKIND PHARMA
- 2025LATANOPROSTGeneric (ANDA)
ANDA 219306 · MICRO LABS
- 2024LATANOPROSTGeneric (ANDA)
ANDA 218257 · GLAND
- 2019LATANOPROSTGeneric (ANDA)
ANDA 206519 · EUGIA PHARMA
- 2016LATANOPROSTGeneric (ANDA)
ANDA 202442 · FDC LTD
- 2013LATANOPROSTGeneric (ANDA)
ANDA 202077 · CARNEGIE
- 2011LATANOPROSTGeneric (ANDA)
ANDA 090887 · EPIC PHARMA LLC
- 2011LATANOPROSTGeneric (ANDA)
ANDA 200925 · AMRING PHARMS
- 2011LATANOPROSTGeneric (ANDA)
ANDA 077697 · APOTEX INC
- 2011LATANOPROSTGeneric (ANDA)
ANDA 201006 · BAUSCH AND LOMB
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.
