Orange Book product · Generic (ANDA)
LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE
At a glance
Apr 17, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 17, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE
Strength
0.5%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 207609
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 216345 · AMNEAL
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.
