FDA Orange Book
Generic for Presamine
Presamine contains imipramine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Presamine is imipramine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Presamine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 4 | AB |
| tablet, oral | 25MG | Discontinued | None | 5 | AB |
| tablet, oral | 50MG | Discontinued | None | 5 | AB |
NDA 011836, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic imipramine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 088292 | AB (A-rated, therapeutically equivalent) | October 21, 1983 | 10MG |
| STRIDES PHARMA INTERNATIONAL AG | 088262 | AB (A-rated, therapeutically equivalent) | October 21, 1983 | 25MG |
| STRIDES PHARMA INTERNATIONAL AG | 088276 | AB (A-rated, therapeutically equivalent) | October 21, 1983 | 50MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 081049 | AB (A-rated, therapeutically equivalent) | June 5, 1990 | 25MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 081050 | AB (A-rated, therapeutically equivalent) | June 5, 1990 | 50MG |
| OXFORD PHARMACEUTICALS LLC | 040751 | AB (A-rated, therapeutically equivalent) | February 28, 2008 | 10MG, 25MG, 50MG |
| LEADING PHARMA LLC | 040903 | AB (A-rated, therapeutically equivalent) | October 24, 2012 | 10MG, 25MG, 50MG |
| SANDOZ INC | 084936 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| SANDOZ INC | 083745 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| SANDOZ INC | 084937 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG |
Questions
Is there a generic for Presamine?
Yes. The generic name for Presamine is imipramine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Presamine?
The active ingredient in Presamine is imipramine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.