Application 203354

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.375MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.75MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current

Application 203354

Related Records#

Application Products#

NDC Listings For This Application#