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Active ingredient

Cevimeline

20 finished FDA listings contain Cevimeline as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
15
Strengths listed
30 mg/1
Brand names in FDA listings
Cevimeline, Evoxac

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 44281

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020989COSETTE2000-01-114
ANDA 091591HIKMA2013-07-082
ANDA 203775RISING2014-06-043
ANDA 204746NOVEL LABS INC2016-12-302
ANDA 216682RUBICON RESEARCH2023-04-063
ANDA 215056AUROBINDO PHARMA2023-04-182
ANDA 218290BIONPHARMA2023-11-081
ANDA 206808MACLEODS PHARMS2024-09-201
ANDA 220267ZYDUS LIFESCIENCES2026-03-112

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.