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LOTEPREDNOL ETABONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2023-12-26

Drug application

FDA Application #
ANDA215550
Application type
Abbreviated New Drug Application (Generic)
Brand name
LOTEPREDNOL ETABONATE
Generic name
Loteprednol Etabonate
Active ingredients
LOTEPREDNOL ETABONATE
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
Marketing status
Prescription
Sponsor
LUPIN
First approval
2023-12-26

Source

Authoritative
Drugs@FDA application overview
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