Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021047
Company: FERRING

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021047

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REPRONEX	MENOTROPINS (FSH;LH)	75 IU/VIAL;75 IU/VIAL	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No
REPRONEX	MENOTROPINS (FSH;LH)	150 IU/VIAL;150 IU/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/1999	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-047_Repronex.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2015	SUPPL-14	Supplement		Label is not available on this site.
11/06/2013	SUPPL-13	Supplement		Label is not available on this site.
10/23/2001	SUPPL-2	Supplement		Label is not available on this site.
07/21/2000	SUPPL-1	Supplement	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-047S001.pdf

Labels for BLA 021047

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21047lbl.pdf