Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076310
Company: STRIDES PHARMA

Products on ANDA 076310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076310.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/26/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/04/2008	SUPPL-2	Labeling		Label is not available on this site.
01/25/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076310

CABERGOLINE

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	No	AB	218618	AMNEAL
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	No	AB	204735	INGENUS PHARMS LLC
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	No	AB	077750	IVAX SUB TEVA PHARMS
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	No	AB	218109	SOMERSET THERAPS LLC
CABERGOLINE	CABERGOLINE	0.5MG	TABLET;ORAL	Prescription	No	AB	076310	STRIDES PHARMA