Assyro AI

FDA Orange Book · active-ingredient family

Imipramine hydrochloride

Imipramine hydrochloride is approved as 3 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOFRANIL · NDA 011838

3

Brand (NDA)

37

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · concentrate, injectable, tablet

ProductApplicantApplicationTEApproved
TOFRANILNOVARTISNDA 011838—Approved Prior to Jan 1, 1982
JANIMINE×3ABBOTTNDA 017895—Approved Prior to Jan 1, 1982
PRESAMINE×3SANOFI AVENTIS USNDA 011836—Approved Prior to Jan 1, 1982

Generic (ANDA) products (37)

ProductApplicantApplicationTEApproved
IMIPRAMINE HYDROCHLORIDE×3LEADINGANDA 040903ABOct 24, 2012
IMIPRAMINE HYDROCHLORIDE×3CHARTWELLANDA 090441—Mar 11, 2010
IMIPRAMINE HYDROCHLORIDE×3OXFORD PHARMSANDA 040751ABFeb 28, 2008
IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 081048—Jun 05, 1990
IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 081049ABJun 05, 1990
IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 081050ABJun 05, 1990
IMIPRAMINE HYDROCHLORIDEPAR PHARMANDA 089422—Jul 14, 1987
IMIPRAMINE HYDROCHLORIDEPAR PHARMANDA 089497—Jul 14, 1987
IMIPRAMINE HYDROCHLORIDERLD×3SPECGX LLCANDA 087846—May 22, 1984
IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 088292ABOct 21, 1983
IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 088262ABOct 21, 1983
IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 088276ABOct 21, 1983
IMIPRAMINE HYDROCHLORIDEWEST WARDANDA 088222—May 26, 1983
IMIPRAMINE HYDROCHLORIDEWEST WARDANDA 088223—May 26, 1983
IMIPRAMINE HYDROCHLORIDEVANGARDANDA 088036—Nov 03, 1982
IMIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 087776—Feb 10, 1982
IMIPRAMINE HYDROCHLORIDEVANGARDANDA 087619—Feb 09, 1982
IMIPRAMINE HYDROCHLORIDEVANGARDANDA 087631—Jan 04, 1982
IMIPRAMINE HYDROCHLORIDENOVARTISANDA 086765—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086269—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086267—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086268—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDE×3ROXANEANDA 083799—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 084936ABApproved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 085200—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 083745ABApproved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 084869—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 084937ABApproved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDESANDOZANDA 085133—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDE×3TEVAANDA 083729—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085220—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085875—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 084252—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085878—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085221—Approved Prior to Jan 1, 1982
IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085877—Approved Prior to Jan 1, 1982
PRAMINE×3ALRAANDA 083827—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.

Imipramine 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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