FDA Orange Book · active-ingredient family
Midodrine hydrochloride
Midodrine hydrochloride is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROAMATINE · NDA 019815
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROAMATINERLD×3 | TAKEDA PHARMS USA | NDA 019815 | — | Sep 06, 1996 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIDODRINE HYDROCHLORIDE×3 | MANKIND PHARMA | ANDA 217271 | AB | Nov 01, 2023 | |
| MIDODRINE HYDROCHLORIDE×3 | NOVUGEN | ANDA 211973 | AB | Oct 17, 2023 | |
| MIDODRINE HYDROCHLORIDE×3 | ALEMBIC | ANDA 214734 | AB | Jan 21, 2021 | |
| MIDODRINE HYDROCHLORIDE×3 | XIROMED | ANDA 207849 | AB | Oct 01, 2020 | |
| MIDODRINE HYDROCHLORIDE×3 | ZYDUS LIFESCIENCES | ANDA 213055 | AB | Sep 01, 2020 | |
| MIDODRINE HYDROCHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 212774 | AB | Aug 10, 2020 | |
| MIDODRINE HYDROCHLORIDE×3 | RUBICON RESEARCH | ANDA 212543 | AB | Aug 19, 2019 | |
| MIDODRINE HYDROCHLORIDE×3 | UNIQUE | ANDA 207613 | AB | Nov 02, 2018 | |
| MIDODRINE HYDROCHLORIDE×3 | PH HEALTH | ANDA 207169 | AB | Oct 29, 2018 | |
| MIDODRINE HYDROCHLORIDE×3 | APOTEX | ANDA 077746 | AB | Sep 12, 2006 | |
| ORVATEN×3 | BEIJING YILING | ANDA 076725 | AB | Nov 03, 2004 | |
| MIDODRINE HYDROCHLORIDE×3 | IMPAX PHARMS | ANDA 076449 | — | May 27, 2004 | |
| MIDODRINE HYDROCHLORIDE×3 | CHARTWELL RX | ANDA 076514 | — | Sep 11, 2003 | |
| MIDODRINE HYDROCHLORIDE×3 | MYLAN PHARMS INC | ANDA 076577 | AB | Sep 10, 2003 |
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.
Midodrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
