Orange Book product · Generic (ANDA)
LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE
At a glance
Jan 29, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 29, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE
Strength
0.5%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 215204
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
- 2024LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 216345 · AMNEAL
- 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.
