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FDA Drug information

Pramipexole Dihydrochloride

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20221013

Version

5

Spl Product Data Elements

Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STEARYL ALCOHOL WHITE TO OFF-WHITE Buff to light brown speckles oval 474 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STEARYL ALCOHOL WHITE TO OFF-WHITE Buff to light brown speckles oval 475 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STEARYL ALCOHOL WHITE TO OFF-WHITE Buff to light brown speckles oval 476 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STEARYL ALCOHOL WHITE TO OFF-WHITE Buff to light brown speckles oval 477 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STEARYL ALCOHOL WHITE TO OFF-WHITE Buff to light brown speckles oval 478 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE ANHYDROUS LACTOSE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARYL ALCOHOL OFF-WHITE OVAL 874 Pramipexole Dihydrochloride Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE ANHYDROUS LACTOSE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROGENATED CASTOR OIL LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARYL ALCOHOL OFF-WHITE OVAL 875

Application Number

ANDA202891

Brand Name

Pramipexole Dihydrochloride

Generic Name

Pramipexole Dihydrochloride

Product Ndc

70771-1332

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1328-3 Pramipexole Dihydrochloride Extended-release Tablets, 0.375 mg R x only 30 tablets NDC 70771-1329-3 Pramipexole Dihydrochloride Extended-release Tablets, 0.75 mg R x only 30 tablets NDC 70771-1330-3 Pramipexole Dihydrochloride Extended-release Tablets, 1.5 mg R x only 30 tablets NDC 70771-1331-3 Pramipexole Dihydrochloride Extended-release Tablets, 2.25 mg R x only 30 tablets NDC 70771-1332-3 Pramipexole Dihydrochloride Extended-release Tablets, 3 mg R x only 30 tablets NDC 70771-1333-3 Pramipexole Dihydrochloride Extended-release Tablets, 3.75 mg R x only 30 tablets NDC 70771-1334-3 Pramipexole Dihydrochloride Extended-release Tablets, 4.5 mg R x only 30 tablets Pramipexole Dihydrochloride ER Tablets Pramipexole Dihydrochloride ER Tablets image 02 Pramipexole Dihydrochloride ER Tablets image 03 Pramipexole dihydrochloride extended-release tablets Pramipexole Dihydrochloride ER Tablets image 04 Pramipexole dihydrochloride extended-release tablets Pramipexole Dihydrochloride ER Tablets image 05

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