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FDA Orange Book · active-ingredient family

Dicyclomine hydrochloride

Dicyclomine hydrochloride is approved as 3 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BENTYL · NDA 007409

3

Brand (NDA)

42

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, injectable, syrup, tablet

ProductApplicantApplicationTEApproved
BENTYLRLD×2ALLERGANNDA 007409—Oct 15, 1984
BENTYLRLD×2ABBVIENDA 008370—Oct 15, 1984
BENTYLRLDAPTALIS PHARMA USNDA 007961—Oct 15, 1984

Generic (ANDA) products (42)

ProductApplicantApplicationTEApproved
DICYCLOMINE HYDROCHLORIDERISINGANDA 219242ABJun 23, 2025
DICYCLOMINE HYDROCHLORIDEPRINSTON INCANDA 218310ABJun 06, 2025
DICYCLOMINE HYDROCHLORIDERISINGANDA 218952ABNov 15, 2024
DICYCLOMINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 214332APNov 01, 2024
DICYCLOMINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 214333APNov 01, 2024
DICYCLOMINE HYDROCHLORIDEANNORA PHARMAANDA 218018ABJul 01, 2024
DICYCLOMINE HYDROCHLORIDEANNORA PHARMAANDA 217566ABMay 07, 2024
DICYCLOMINE HYDROCHLORIDEPRINSTON INCANDA 217531ABAug 30, 2023
DICYCLOMINE HYDROCHLORIDEBIONPHARMAANDA 217916ABAug 04, 2023
DICYCLOMINE HYDROCHLORIDETWI PHARMSANDA 216782ABJun 01, 2023
DICYCLOMINE HYDROCHLORIDECOREPHARMAANDA 216639ABMar 24, 2023
DICYCLOMINE HYDROCHLORIDETWI PHARMSANDA 217054ABDec 27, 2022
DICYCLOMINE HYDROCHLORIDE×2RUBICON RESEARCHANDA 216736ABDec 14, 2022
DICYCLOMINE HYDROCHLORIDECOREPHARMAANDA 216760ABNov 28, 2022
DICYCLOMINE HYDROCHLORIDENOVITIUM PHARMAANDA 214721AAApr 23, 2021
DICYCLOMINE HYDROCHLORIDEHIKMAANDA 212286AAMay 22, 2020
DICYCLOMINE HYDROCHLORIDEPRAXGEN PHARMSANDA 212058—Apr 26, 2019
DICYCLOMINE HYDROCHLORIDEHIKMAANDA 210788—Feb 11, 2019
DICYCLOMINE HYDROCHLORIDENEXUSANDA 206468—Feb 01, 2019
DICYCLOMINE HYDROCHLORIDEFRESENIUS KABI USAANDA 210257APJan 25, 2019
DICYCLOMINE HYDROCHLORIDESLATE RUN PHARMAANDA 207076APNov 02, 2018
DICYCLOMINE HYDROCHLORIDEFOSUN PHARMAANDA 210979APJul 02, 2018
DICYCLOMINE HYDROCHLORIDERENEW PHARMSANDA 207084—May 04, 2018
DICYCLOMINE HYDROCHLORIDEAM REGENTANDA 208353APFeb 17, 2017
DICYCLOMINE HYDROCHLORIDEPH HEALTHANDA 040169AAMar 24, 2005
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)HIKMAANDA 040465APJun 30, 2003
DICYCLOMINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 040319ABSep 07, 1999
DICYCLOMINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 040317ABSep 07, 1999
DICYCLOMINE HYDROCHLORIDELANNETTANDA 040230ABFeb 26, 1999
DICYCLOMINE HYDROCHLORIDEWEST WARDANDA 040204ABFeb 28, 1997
DICYCLOMINE HYDROCHLORIDEHIKMA PHARMSANDA 040161ABOct 01, 1996
DICYCLOMINE HYDROCHLORIDEPIONEER PHARMSANDA 089361—Jan 10, 1989
DICYCLOMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 084505—Oct 21, 1986
DICYCLOMINE HYDROCHLORIDEPIONEER PHARMSANDA 088585—Aug 20, 1986
DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 085223ABJul 30, 1986
DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 085082ABJun 19, 1986
DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 083179—Feb 12, 1986
DICYCLOMINE HYDROCHLORIDEDR REDDYSANDA 080614—Feb 11, 1986
DICYCLOMINE HYDROCHLORIDEWATSON LABSANDA 084361—Feb 06, 1986
DICYCLOMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 084600—Jul 29, 1985
DICYCLOMINE HYDROCHLORIDELANNETTANDA 084285ABApproved Prior to Jan 1, 1982
DICYCLOMINE HYDROCHLORIDEALPHARMA US PHARMSANDA 084479—Approved Prior to Jan 1, 1982

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.

Dicyclomine 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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