Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075528
Company: COSETTE

Products on ANDA 075528

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075528

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75528ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2025	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/23/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/19/2013	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 075528

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	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