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FDA Orange Book · active-ingredient family

Hydrochlorothiazide; losartan potassium

Hydrochlorothiazide; losartan potassium is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HYZAAR · NDA 020387

1

Brand (NDA)

18

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
HYZAARRLD×3ORGANONNDA 020387ABApr 28, 1995

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3HETERO LABS LTD VANDA 219869ABMay 27, 2026
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3GRANULESANDA 218015Sep 29, 2023
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3PRINSTON INCANDA 204901ABNov 06, 2017
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3UNICHEMANDA 204832ABJul 21, 2017
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3IPCA LABS LTDANDA 201682Mar 01, 2013
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3JUBILANT CADISTAANDA 201845ABSep 18, 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3MACLEODS PHARMS LTDANDA 202289ABAug 09, 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3ALEMBIC PHARMS LTDANDA 091617ABFeb 17, 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3WATSON LABSANDA 200180Jan 12, 2011
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3APOTEXANDA 090150Oct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3AUROBINDO PHARMAANDA 091629ABOct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3CHARTWELL RXANDA 077948ABOct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3HIKMAANDA 077732Oct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3LUPIN LTDANDA 078245ABOct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3MYLANANDA 091652Oct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3TORRENT PHARMSANDA 090528Oct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×2ZYDUS PHARMS USA INCANDA 078385ABOct 06, 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE×3TEVA PHARMSANDA 077157ABApr 06, 2010

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Hydrochlorothiazide; losartan potassium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.