Orange Book product · Generic (ANDA)
PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE
At a glance
Apr 21, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 21, 2016
10 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Strength
0.375MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 201963
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PRAMIPEXOLE DIHYDROCHLORIDE
- 2010MIRAPEX ERBrand (NDA)
NDA 022421 · BOEHRINGER INGELHEIM
- 1997MIRAPEXBrand (NDA)
NDA 020667 · BOEHRINGER INGELHEIM
- 2022PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 213444 · NOVAST LABS
- 2021PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 212797 · XIAMEN LP PHARM CO
- 2019PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 204518 · ALEMBIC
- 2018PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 207011 · UNICHEM
- 2018PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 211088 · RISING
- 2017PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 202891 · ZYDUS PHARMS
- 2016PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 203615 · ACTAVIS ELIZABETH
- 2016PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 206156 · MACLEODS PHARMS LTD
- 2015PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 203354 · DR REDDYS
- 2014PRAMIPEXOLE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 202353 · CHARTWELL RX
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.
