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): 218618
Company: AMNEAL

Products on ANDA 218618

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 218618

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218618

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

Top