Orange Book product · Brand (NDA)
PROAMATINE
MIDODRINE HYDROCHLORIDE
At a glance
Sep 06, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 06, 1996
30 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDODRINE HYDROCHLORIDE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019815
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217271 · MANKIND PHARMA
- 2023MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211973 · NOVUGEN
- 2021MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214734 · ALEMBIC
- 2020MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207849 · XIROMED
- 2020MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213055 · ZYDUS LIFESCIENCES
- 2020MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212774 · AUROBINDO PHARMA LTD
- 2019MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212543 · RUBICON RESEARCH
- 2018MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207613 · UNIQUE
- 2018MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207169 · PH HEALTH
- 2006MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077746 · APOTEX
- 2004ORVATENGeneric (ANDA)
ANDA 076725 · BEIJING YILING
- 2004MIDODRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076449 · IMPAX PHARMS
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.
