Imipramine pamoate
Imipramine pamoate: 1 brand, 3 generics; first approved Apr 16, 2010; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- TOFRANIL-PMRLDSPECGX LLCNDA 017090-4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 150MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 125MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued -
Generic (ANDA) products (3)
- IMIPRAMINE PAMOATERISINGANDA 20233820134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 100MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 125MG HYDROCHLORIDE CAPSULE ORAL Discontinued - EQ 150MG HYDROCHLORIDE CAPSULE ORAL Discontinued - - IMIPRAMINE PAMOATERSHIKMAANDA 09109920104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 100MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 125MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 150MG HYDROCHLORIDE CAPSULE ORAL Rx AB - IMIPRAMINE PAMOATELUPIN LTDANDA 09044420104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 100MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 125MG HYDROCHLORIDE CAPSULE ORAL Rx AB EQ 150MG HYDROCHLORIDE CAPSULE ORAL Rx AB
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.
Approval history
Approvals span 2010–2013 across 4 FDA applications.
Imipramine pamoate: 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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