Assyro AI

FDA Orange Book · active-ingredient family

Bethanechol chloride

Bethanechol chloride is approved as 1 brand and 52 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:URECHOLINE · NDA 006536

1

Brand (NDA)

52

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
URECHOLINERLD×5TEVA BRANDED PHARMNDA 006536—Approved Prior to Jan 1, 1982

Generic (ANDA) products (52)

ProductApplicantApplicationTEApproved
BETHANECHOL CHLORIDE×4HERITAGE PHARMAANDA 091256AAMay 04, 2010
BETHANECHOL CHLORIDE×4SUN PHARM INDS INCANDA 040897—Apr 22, 2009
BETHANECHOL CHLORIDE×4LANNETT CO INCANDA 040677—Mar 27, 2008
BETHANECHOL CHLORIDE×4AMNEAL PHARMANDA 040855AANov 21, 2007
BETHANECHOL CHLORIDE×4CHARTWELL RXANDA 040728AAOct 26, 2007
BETHANECHOL CHLORIDE×4IMPAX LABSANDA 040721—Nov 01, 2006
BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 040633AAJun 01, 2005
BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 040634AAJun 01, 2005
BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 040635AAJun 01, 2005
BETHANECHOL CHLORIDEUPSHER SMITH LABSANDA 040636AAJun 01, 2005
BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 040552—Oct 28, 2004
BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 040553—Oct 28, 2004
BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 040554—Oct 28, 2004
BETHANECHOL CHLORIDEACTAVIS ELIZABETHANDA 040551—Oct 28, 2004
BETHANECHOL CHLORIDEABLEANDA 040492—Jul 27, 2004
BETHANECHOL CHLORIDEABLEANDA 040483—Jul 27, 2004
BETHANECHOL CHLORIDEABLEANDA 040485—Jul 27, 2004
BETHANECHOL CHLORIDEABLEANDA 040509—Jul 27, 2004
BETHANECHOL CHLORIDEWOCKHARDTANDA 040532—Sep 29, 2003
BETHANECHOL CHLORIDEWOCKHARDTANDA 040533—Sep 29, 2003
BETHANECHOL CHLORIDEWOCKHARDTANDA 040534—Sep 29, 2003
BETHANECHOL CHLORIDEWOCKHARDTANDA 040518—Sep 29, 2003
URECHOLINEODYSSEY PHARMSANDA 089095—Dec 19, 1985
URECHOLINEODYSSEY PHARMSANDA 089096—Dec 19, 1985
URECHOLINERLDODYSSEY PHARMSANDA 088440—May 29, 1984
URECHOLINERLDODYSSEY PHARMSANDA 088441—May 29, 1984
BETHANECHOL CHLORIDEASCOTANDA 088288—Jun 08, 1983
BETHANECHOL CHLORIDEASCOTANDA 088289—Jun 08, 1983
BETHANECHOL CHLORIDEIVAX SUB TEVA PHARMSANDA 084689—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDELANNETTANDA 084702—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDELANNETTANDA 084712—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDELANNETTANDA 084074—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDESANDOZANDA 084353—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDESANDOZANDA 084378—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDESANDOZANDA 084379—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDESANDOZANDA 084383—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDESANDOZANDA 084384—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 084402—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085230—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085841—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 084408—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085228—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085842—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 084441—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085229—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 085839—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 087397—Approved Prior to Jan 1, 1982
BETHANECHOL CHLORIDEWATSON LABSANDA 087444—Approved Prior to Jan 1, 1982
DUVOIDCHARTWELL RXANDA 086262AAApproved Prior to Jan 1, 1982
DUVOIDCHARTWELL RXANDA 086263AAApproved Prior to Jan 1, 1982
DUVOIDCHARTWELL RXANDA 085882AAApproved Prior to Jan 1, 1982
MYOTONACHOL×3GLENWOODANDA 084188—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.

Bethanechol chloride — frequently asked questions

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

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