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Applicant, as named in the Orange Book

Lederle

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis

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Recent events

25 Oct 2026Neptazane · Generic approved 9 Feb 2026

Orange Book data as of 26 Oct 2026. Dates are as listed in the FDA Orange Book and do not account for litigation, settlements or at-risk launches. cliffwatch reports regulatory facts and is not investment advice.