Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215574
Company: HETERO LABS LTD V

Products on ANDA 215574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSPEMIFENE	OSPEMIFENE	60MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215574Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2024	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215574

OSPEMIFENE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OSPEMIFENE	OSPEMIFENE	60MG	TABLET;ORAL	Prescription	No	AB	215574	HETERO LABS LTD V
OSPHENA	OSPEMIFENE	60MG	TABLET;ORAL	Prescription	Yes	AB	203505	DUCHESNAY