Details for New Drug Application (NDA): 201963

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NDA 201963 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty NDAs. It is available from twenty-four suppliers. Additional details are available on the PRAMIPEXOLE DIHYDROCHLORIDE profile page.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Tradename:	PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:	Actavis Elizabeth
Ingredient:	pramipexole dihydrochloride
Patents:	0

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.375MG
Approval Date:	Apr 21, 2016	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.75MG
Approval Date:	Apr 21, 2016	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.5MG
Approval Date:	Apr 21, 2016	TE:	AB	RLD:	No

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