Orange Book product · Generic (ANDA)
LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE
At a glance
Dec 13, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE
Strength
0.2%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 216345
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LOTEPREDNOL ETABONATE
- 2020EYSUVISBrand (NDA)
NDA 210933 · ALCON LABS INC
- 2019LOTEMAX SMBrand (NDA)
NDA 208219 · BAUSCH AND LOMB INC
- 2018INVELTYSBrand (NDA)
NDA 210565 · ALCON LABS INC
- 2012LOTEMAXBrand (NDA)
NDA 202872 · BAUSCH AND LOMB INC
- 2011LOTEMAXBrand (NDA)
NDA 200738 · BAUSCH AND LOMB
- 1998ALREXBrand (NDA)
NDA 020803 · BAUSCH AND LOMB
- 1998LOTEMAXBrand (NDA)
NDA 020583 · BAUSCH AND LOMB
- 1998LOTEMAXBrand (NDA)
NDA 020841 · PHARMOS
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 218087 · LUPIN
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 217484 · AMNEAL
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 215204 · PADAGIS US
- 2024LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 215203 · PADAGIS US
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.
