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Active ingredient

Tamsulosin

63 finished FDA listings contain Tamsulosin as their only active ingredient; 4 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
TAMSULOSIN HYDROCHLORIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
38
Strengths listed
.4 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 77492

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
ANDA 090377IMPAX LABS2010-03-022
ANDA 078225ZYDUS PHARMS USA INC2010-04-279
ANDA 078015SANDOZ2010-04-271
ANDA 078801SYNTHON BV2010-04-273
ANDA 090931SUN PHARM INDS LTD2010-07-152
ANDA 202433AUROBINDO PHARMA LTD2013-04-3032
ANDA 204645MACLEODS PHARMS2017-01-204
ANDA 207405ALKEM LABS LTD2017-08-118
ANDA 214730ASCENT PHARMS INC2022-05-042

Official labeling on DailyMed

Showing the 12 most recent of 61 labels.

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