Details for New Drug Application (NDA): 212080
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NDA 212080 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Hikma, Sentiss, Sun Pharm, Lupin Ltd, and Padagis Us, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the LOTEPREDNOL ETABONATE profile page.
The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 212080
| Tradename: | LOTEPREDNOL ETABONATE |
| Applicant: | Sentiss |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Pharmacology for NDA: 212080
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212080
Suppliers and Packaging for NDA: 212080
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOTEPREDNOL ETABONATE | loteprednol etabonate | GEL;OPHTHALMIC | 212080 | ANDA | ARMAS PHARMACEUTICALS INC. | 72485-630 | 72485-630-05 | 1 BOTTLE, DROPPER in 1 CARTON (72485-630-05) / 5 g in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Feb 10, 2021 | TE: | AB | RLD: | No | ||||
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