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Active ingredient

Telmisartan

80 finished FDA listings contain Telmisartan as their only active ingredient; 40 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
TELMISARTAN
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
28
Strengths listed
20 mg/1 · 40 mg/1 · 80 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 73494

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 078710CHARTWELL RX2014-01-083
ANDA 090032GLENMARK PHARMS LTD2014-07-077
ANDA 202397MYLAN2014-07-075
ANDA 202130ALEMBIC2014-07-076
ANDA 203325ZYDUS PHARMS2014-08-266
ANDA 206511AUROBINDO PHARMA2015-09-033
ANDA 204415AMNEAL PHARMS2015-09-089
ANDA 205150ADAPTIS2015-10-3011
ANDA 204164JUBILANT GENERICS2016-08-223
ANDA 207882PRINSTON INC2017-05-038
ANDA 208605CADILA PHARMS LTD2017-07-259
ANDA 218157MANKIND PHARMA2024-10-153
ANDA 203986MACLEODS PHARMS2025-01-157

Official labeling on DailyMed

Showing the 12 most recent of 39 labels.

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