Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020328
Company: ORGANON USA INC

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

Products on BLA 020328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HUMEGON	MENOTROPINS (FSH;LH)	75 IU/VIAL;75 IU/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
HUMEGON	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 020328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/1994	ORIG-1	Approval		N/A		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/1999	SUPPL-4	Supplement		Label is not available on this site.
04/02/1999	SUPPL-3	Supplement		Label is not available on this site.
02/21/1997	SUPPL-2	Supplement		Label is not available on this site.
07/06/1995	SUPPL-1	Supplement		Label is not available on this site.