Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218391
Company: XIROMED

Products on ANDA 218391

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218391

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218391Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 218391

PROGESTERONE

INSERT;VAGINAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENDOMETRIN	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	Yes	AB	022057	FERRING
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	No	AB	218391	XIROMED