Orange Book product · Brand (NDA)
LOTEMAX
LOTEPREDNOL ETABONATE
At a glance
Apr 15, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 2011
15 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE
Strength
0.5%
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 200738
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.
- 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
- 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
- 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.
