FDA Orange Book
Generic for Proamatine
Proamatine contains midodrine. 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 Proamatine is midodrine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Proamatine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 12 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 12 | AB |
| tablet, oral | 5MG | Discontinued | None | 12 | AB |
NDA 019815, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic midodrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 076577 | AB (A-rated, therapeutically equivalent) | September 10, 2003 | 10MG, 2.5MG, 5MG |
| BEIJING YILING BIO-ENGINEERING TECHNOLOGY CO LTD | 076725 | AB (A-rated, therapeutically equivalent) | November 3, 2004 | 10MG, 2.5MG, 5MG |
| APOTEX INC | 077746 | AB (A-rated, therapeutically equivalent) | September 12, 2006 | 10MG, 2.5MG, 5MG |
| PH HEALTH LTD | 207169 | AB (A-rated, therapeutically equivalent) | October 29, 2018 | 10MG, 2.5MG, 5MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 207613 | AB (A-rated, therapeutically equivalent) | November 2, 2018 | 10MG, 2.5MG, 5MG |
| RUBICON RESEARCH LTD | 212543 | AB (A-rated, therapeutically equivalent) | August 19, 2019 | 10MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 212774 | AB (A-rated, therapeutically equivalent) | August 10, 2020 | 10MG, 2.5MG, 5MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 213055 | AB (A-rated, therapeutically equivalent) | September 1, 2020 | 10MG, 2.5MG, 5MG |
| XIROMED PHARMA ESPANA SL | 207849 | AB (A-rated, therapeutically equivalent) | October 1, 2020 | 10MG, 2.5MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 214734 | AB (A-rated, therapeutically equivalent) | January 21, 2021 | 10MG, 2.5MG, 5MG |
| NOVUGEN PHARMA MALAYSIA SDN BHD | 211973 | AB (A-rated, therapeutically equivalent) | October 17, 2023 | 10MG, 2.5MG, 5MG |
| MANKIND PHARMA LTD | 217271 | AB (A-rated, therapeutically equivalent) | November 1, 2023 | 10MG, 2.5MG, 5MG |
Questions
Is there a generic for Proamatine?
Yes. The generic name for Proamatine is midodrine. 12 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 Proamatine?
The active ingredient in Proamatine is midodrine, 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.