Details for New Drug Application (NDA): 212450
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The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 212450
Tradename: | LOTEPREDNOL ETABONATE |
Applicant: | Sun Pharm |
Ingredient: | loteprednol etabonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212450
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212450
Suppliers and Packaging for NDA: 212450
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 212450 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-232 | 62756-232-55 | 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE |
LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 212450 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-232 | 62756-232-56 | 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Feb 26, 2021 | TE: | AB | RLD: | No |
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