Details for New Drug Application (NDA): 216345
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NDA 216345 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Hikma, Lupin Ltd, Sentiss, Sun Pharm, Amneal, and Padagis Us, and is included in thirteen NDAs. It is available from six 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 216345
| Tradename: | LOTEPREDNOL ETABONATE |
| Applicant: | Amneal |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Pharmacology for NDA: 216345
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216345
Suppliers and Packaging for NDA: 216345
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 216345 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1366 | 60219-1366-3 | 1 BOTTLE in 1 CARTON (60219-1366-3) / 5 mL in 1 BOTTLE |
| LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 216345 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1367 | 60219-1367-6 | 1 BOTTLE in 1 CARTON (60219-1367-6) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.2% | ||||
| Approval Date: | Dec 13, 2024 | TE: | AB | RLD: | No | ||||
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