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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218109
Company: SOMERSET THERAPS LLC

Products on ANDA 218109

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 218109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218109

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 INTL

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