An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203615
Company: ACTAVIS ELIZABETH

Products on ANDA 203615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/03/2017	ORIG-2	Approval				Label is not available on this site.
10/14/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203615

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 2.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203615	ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204518	ALEMBIC
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206156	MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213444	NOVAST LABS
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202891	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 3.75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203615	ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204518	ALEMBIC
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206156	MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213444	NOVAST LABS
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202891	ZYDUS PHARMS

Top