Details for New Drug Application (NDA): 215384
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NDA 215384 describes LOTEPREDNOL ETABONATE, which is a drug marketed by Hikma, Sentiss, Sun Pharm, Lupin Ltd, and Padagis Us, and is included in nine NDAs. It is available from three 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 215384
| Tradename: | LOTEPREDNOL ETABONATE |
| Applicant: | Sun Pharm |
| Ingredient: | loteprednol etabonate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215384
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Aug 9, 2023 | TE: | AB | RLD: | No | ||||
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