Basic Information
Pramipexole Dihydrochloride
65862-606
Regulatory Information
65862-606
ANDA202633
C73584
February 17, 2024
USA
These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
Human Prescription Drug Label
14
Company Information
650082092
Active Ingredients
Inactive Ingredients
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
POVIDONE K90
Code: RDH86HJV5Z
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
Active Moieties
PRAMIPEXOLE
Code: 83619PEU5T