Application 202206

Type: ANDA
Sponsor: ANCHEN PHARMS

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	2.25MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3.75MG	No	No
007	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
10370-251	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-251	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-251	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-251	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-251	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-252	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-252	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-252	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-252	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-252	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-253	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-253	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-253	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-253	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-253	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-254	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-254	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-254	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-254	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-254	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-255	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-255	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-255	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-255	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-305	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-305	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-305	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-305	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-305	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-306	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-306	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-306	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-306	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
10370-306	Pramipexole Dihydrochloride	Pramipexole	Par Pharmaceutical, Inc.	ANDA	Current
42291-557	Pramipexole Dihydrochloride	Pramipexole	AvKARE, Inc.	ANDA	Current

Application 202206

Related Records#

Application Products#

NDC Listings For This Application#