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Active ingredient

Clomipramine

51 finished FDA listings contain Clomipramine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CLOMIPRAMINE HYDROCHLORIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
17
Strengths listed
25 mg/1 · 50 mg/1 · 75 mg/1
Brand names in FDA listings
Anafranil, Clomipramine Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2597

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 019906SPECGX LLC1989-12-296
ANDA 074694TARO1996-12-3110
ANDA 208961ZYDUS PHARMS2017-12-273
ANDA 209294LUPIN2018-11-213
ANDA 211767MANKIND PHARMA2019-04-085
ANDA 211364LEADING2020-02-076
ANDA 213219MICRO LABS2020-06-223
ANDA 212285UNIQUE2020-08-073
ANDA 213897AJANTA PHARMA LTD2020-10-023
ANDA 211822ALEMBIC2021-08-046
ANDA 216440AUROBINDO PHARMA2023-03-203

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

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