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PRAMIPEXOLE DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2012-09-20

Drug application

FDA Application #
ANDA202164
Application type
Abbreviated New Drug Application (Generic)
Brand name
PRAMIPEXOLE DIHYDROCHLORIDE
Generic name
PRAMIPEXOLE DIHYDROCHLORIDE
Active ingredients
PRAMIPEXOLE DIHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Discontinued
Sponsor
MACLEODS PHARMS LTD
Manufacturer
Macleods Pharmaceuticals Limited
First approval
2012-09-20

Source

Authoritative
Drugs@FDA application overview
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