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): 220673
Company: ASCENT PHARMS INC

Products on ANDA 220673

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220673

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220673

CLOMIPHENE CITRATE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	219406	ACCORD HLTHCARE
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	216739	APPCO
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	220673	ASCENT PHARMS INC
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	075528	COSETTE
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	219781	NOVITIUM PHARMA
CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	216545	RUBICON
MILOPHENE	CLOMIPHENE CITRATE	50MG	TABLET;ORAL	Prescription	No	AB	072196	GRANATA BIO CORP

Top