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PRAMIPEXOLE DIHYDROCHLORIDE

ANDA

PRAMIPEXOLE DIHYDROCHLORIDE | A203615 | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain19 active DMFs3 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

AMINO CHEMICALS LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 182972005

ALEMBIC PHARMACEUTICALS LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 188362005

HETERO DRUGS LTDPRAMIPEXOLE DIHYDROCHLORIDE

DMF 198532006

WAVELENGTH ENTERPRISES LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 201162007

ZYDUS LIFESCIENCES LTDPRAMIPEXOLE DIHYDROCHLORIDE USP (MONOHYDRATE)

DMF 201302007

OLON SPAPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 210822007

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 214132008

TORRENT PHARMACEUTICALS LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 216312008

MATRIX PHARMACORP PRIVATE LTDPRAMIPEXOLE DIHYDROCHLORIDE USP

DMF 217122008

CURIA SPAIN SAUPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

DMF 217912008

SUN PHARMACEUTICAL INDUSTRIES LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 218992008

PH HEALTH LTDPRAMIPEXOLE DIHYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 222092008

APITORIA PHARMA PRIVATE LTDPRAMIPEXOLE DIHYDROCHLORIDE USP

DMF 227892009

ORBION PHARMACEUTICALS PRIVATE LTDPRAMIPEXOLE DIHYDROCHLORIDE

DMF 228602009

MACLEODS PHARMACEUTICALS LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 231632009

MSN LABORATORIES PRIVATE LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP [ROUTE CODE PP]

DMF 239002010

WOCKHARDT LTDPRAMIPEXOLE DIHYDROCHLORIDE USP

DMF 247812011

UNICHEM LABORATORIES LTDPRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 259072012

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDPRAMIPEXOLE DIHYDROCHLORIDE NON-STERILE DRUG SUBSTANCE

DMF 412912025

CIPLA LTDInactivePRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 187012005

APOTEX PHARMACHEM INDIA PVT LTDInactivePRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

DMF 210952007

ERREGIERRE SPAInactivePRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR

DMF 243312010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 2.25MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 14, 2016

No patent or exclusivity listings for this strength.

#002 — 3.75MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 3, 2017