NDC 17478-830

Loteprednol Etabonate

Loteprednol Etabonate

Loteprednol Etabonate is a Ophthalmic Gel in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Loteprednol Etabonate.

Product ID17478-830_d4bb0801-c5f0-49d1-a1d1-c163aa8c9f93
NDC17478-830
Product TypeHuman Prescription Drug
Proprietary NameLoteprednol Etabonate
Generic NameLoteprednol Etabonate
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-02-10
Marketing CategoryANDA / ANDA
Application NumberANDA212080
Labeler NameAkorn, Inc.
Substance NameLOTEPREDNOL ETABONATE
Active Ingredient Strength5 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 17478-830-05

1 BOTTLE, DROPPER in 1 CARTON (17478-830-05) > 5 g in 1 BOTTLE, DROPPER
Marketing Start Date2021-02-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Loteprednol Etabonate" or generic name "Loteprednol Etabonate"

NDCBrand NameGeneric Name
17478-830Loteprednol EtabonateLoteprednol Etabonate
24208-508Loteprednol Etabonateloteprednol etabonate
50383-265Loteprednol EtabonateLoteprednol Etabonate
68682-299Loteprednol Etabonateloteprednol etabonate
24208-353ALREXloteprednol etabonate
71571-333Eysuvisloteprednol etabonate
71571-121Inveltysloteprednol etabonate
24208-299LOTEMAXloteprednol etabonate
24208-443Lotemaxloteprednol etabonate
24208-503LOTEMAXloteprednol etabonate
24208-507Lotemax SMloteprednol etabonate

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.