Details for New Drug Application (NDA): 218087
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NDA 218087 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 218087
| Tradename: | LOTEPREDNOL ETABONATE |
| Applicant: | Lupin Ltd |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 218087
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 0.38% | ||||
| Approval Date: | Jun 30, 2025 | TE: | AB | RLD: | No | ||||
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