Details for New Drug Application (NDA): 215933
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NDA 215933 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Hikma, Lupin Ltd, Sentiss, Sun Pharm, Amneal, Padagis Us, and Alembic, and is included in fourteen NDAs. It is available from eight suppliers. Additional details are available on the LOTEPREDNOL ETABONATE profile page.
The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate; tobramycin. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the loteprednol etabonate; tobramycin profile page.
The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate; tobramycin. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the loteprednol etabonate; tobramycin 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 | Sentiss Pharmaceuticals LLC | 70244-035 | 70244-035-01 | 1 BOTTLE, DROPPER in 1 CARTON (70244-035-01) / 5 mL in 1 BOTTLE, DROPPER |
| LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 215933 | ANDA | Sentiss Pharmaceuticals LLC | 70244-035 | 70244-035-02 | 1 BOTTLE, DROPPER in 1 CARTON (70244-035-02) / 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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