Orange Book product · Generic (ANDA)
MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE
At a glance
Aug 19, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDODRINE HYDROCHLORIDE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 212543
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MIDODRINE HYDROCHLORIDE
- 1996PROAMATINEBrand (NDA)
NDA 019815 · TAKEDA PHARMS USA
- 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
- 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.
