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FDA Orange Book · active-ingredient family

Tamsulosin hydrochloride

Tamsulosin hydrochloride is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLOMAX · NDA 020579

1

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
FLOMAXRLDSANOFINDA 020579—Apr 15, 1997

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
TAMSULOSIN HYDROCHLORIDERISINGANDA 219767ABMay 01, 2025
TAMSULOSIN HYDROCHLORIDEASCENT PHARMS INCANDA 214730ABMay 04, 2022
TAMSULOSIN HYDROCHLORIDECHARTWELL RXANDA 211885ABOct 17, 2019
TAMSULOSIN HYDROCHLORIDEALKEM LABS LTDANDA 207405ABAug 11, 2017
TAMSULOSIN HYDROCHLORIDEMACLEODS PHARMS LTDANDA 204645ABJan 20, 2017
TAMSULOSIN HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 202433ABApr 30, 2013
TAMSULOSIN HYDROCHLORIDEPH HEALTHANDA 202010—Jan 04, 2013
TAMSULOSIN HYDROCHLORIDESUN PHARM INDS LTDANDA 090931—Jul 15, 2010
TAMSULOSIN HYDROCHLORIDEPHARMOBEDIENTANDA 090408—Apr 27, 2010
TAMSULOSIN HYDROCHLORIDESANDOZANDA 078015ABApr 27, 2010
TAMSULOSIN HYDROCHLORIDESCIEGEN PHARMSANDA 078938ABApr 27, 2010
TAMSULOSIN HYDROCHLORIDESYNTHON BVANDA 078801ABApr 27, 2010
TAMSULOSIN HYDROCHLORIDETEVA PHARMSANDA 077630ABApr 27, 2010
TAMSULOSIN HYDROCHLORIDEZYDUS PHARMS USA INCANDA 078225ABApr 27, 2010
TAMSULOSIN HYDROCHLORIDEIMPAX LABSANDA 090377ABMar 02, 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.

Tamsulosin hydrochloride — frequently asked questions

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

Agent CTA Background

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