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

New Drug Application (NDA): 203505
Company: DUCHESNAY

Products on NDA 203505

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSPHENA	OSPEMIFENE	60MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203505Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203505Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203505s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203505Orig1s022ltr.pdf
01/25/2019	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203505s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203505Orig1s015ltr.pdf
10/26/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203505s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203505Orig1s014ltr.pdf
03/17/2017	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/24/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/24/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/24/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/20/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/23/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/25/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203505Orig1s005ltr.pdf
05/02/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/08/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/27/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/13/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203505

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203505s022lbl.pdf
01/25/2019	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203505s015lbl.pdf
10/26/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203505s014lbl.pdf
02/25/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf
02/26/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf

Therapeutic Equivalents for NDA 203505

OSPHENA

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

Top