Details for New Drug Application (NDA): 215933
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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 215933
Tradename: | LOTEPREDNOL ETABONATE |
Applicant: | Sentiss |
Ingredient: | loteprednol etabonate |
Patents: | 0 |
Pharmacology for NDA: 215933
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215933
Suppliers and Packaging for NDA: 215933
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 215933 | ANDA | ARMAS PHARMACEUTICALS INC. | 72485-653 | 72485-653-05 | 1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPER |
LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 215933 | ANDA | ARMAS PHARMACEUTICALS INC. | 72485-653 | 72485-653-10 | 1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.2% | ||||
Approval Date: | Apr 12, 2023 | TE: | AB | RLD: | No |
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