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Active ingredient

Lorazepam

148 finished FDA listings contain Lorazepam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LORAZEPAM
Dosage forms
Capsule, Extended Release, Concentrate, Injection, Injection, Solution, Liquid, Solution, Concentrate, Tablet
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
39
Strengths listed
.5 mg/1 · 1 mg/1 · 1.5 mg/1 · 2 mg/1 · 2 mg/ml · 3 mg/1 · 4 mg/ml
Brand names in FDA listings
Ativan, Loreev Xr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6470

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 017794BAUSCH1977-09-303
NDA 018140HIKMA1980-07-2514
ANDA 071591CHARTWELL RX1987-10-133
ANDA 072755HIKMA1991-06-281
ANDA 072927WATSON LABS1991-10-318
ANDA 072926WATSON LABS1991-10-319
ANDA 072928WATSON LABS1991-10-315
ANDA 074243HOSPIRA1994-04-122
ANDA 076045SUN PHARM INDS LTD2001-08-2919
ANDA 076150INTL MEDICATION SYS2004-11-151
ANDA 077396ANI PHARMS2006-12-133
ANDA 078203LEADING2007-07-3035
ANDA 079244CHARTWELL MOLECULAR2009-04-281
ANDA 091383AMNEAL PHARMS2009-12-231
ANDA 090260PHARM ASSOC2010-06-153
ANDA 203572AUROBINDO PHARMA2017-12-2228
NDA 214826ALMATICA2021-08-275
ANDA 217598FRESENIUS KABI USA2024-11-182
ANDA 218597GRAVITI PHARMS2025-07-245

Official labeling on DailyMed

Showing the 12 most recent of 103 labels.

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