FDA Orange Book · active-ingredient family
Imipramine hydrochloride
Imipramine hydrochloride: 3 brands, 37 generics; first approved Jan 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
37
Listed patents
0
Presentations
58
Brand (NDA) products
Originator applications
- NOVARTISNDA 011838-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG/ML INJECTABLE INJECTION Discontinued - - ABBOTTNDA 017895-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - - SANOFI AVENTIS USNDA 011836-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued -
Generic (ANDA) products (37)
Abbreviated applications
- IMIPRAMINE HYDROCHLORIDELEADINGANDA 04090320123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDECHARTWELLANDA 09044120103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEOXFORD PHARMSANDA 04075120083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0810481990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0810491990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0810501990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDEPAR PHARMANDA 0894221987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEPAR PHARMANDA 0894971987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDERLDSPECGX LLCANDA 08784619843 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0882921983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0882621983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 0882761983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDEWEST WARDANDA 0882221983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWEST WARDANDA 0882231983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEVANGARDANDA 0880361982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEUSL PHARMAANDA 0877761982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEVANGARDANDA 0876191982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEVANGARDANDA 0876311982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDENOVARTISANDA 086765-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML CONCENTRATE ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086269-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086267-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDELEDERLEANDA 086268-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEROXANEANDA 083799-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDESANDOZANDA 084936-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESANDOZANDA 085200-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDESANDOZANDA 083745-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESANDOZANDA 084869-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDESANDOZANDA 084937-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - IMIPRAMINE HYDROCHLORIDESANDOZANDA 085133-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDETEVAANDA 083729-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085220-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085875-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 084252-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085878-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085221-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - IMIPRAMINE HYDROCHLORIDEWATSON LABSANDA 085877-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - ALRAANDA 083827-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - 25MG TABLET ORAL Discontinued - 50MG TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
45 yr 5 mo ago
Most recent approval
14 yr 2 mo ago
Approvals span 1982–2012 across 40 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3793%
Imipramine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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