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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020168
Company: GENENTECH

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

Products on BLA 020168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUTROPIN	SOMATROPIN	5MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
NUTROPIN	SOMATROPIN	10MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1993	ORIG-1	Approval		N/A; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2016	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf
09/17/2001	SUPPL-18	Supplement		Label is not available on this site.
05/02/2001	SUPPL-17	Supplement		Label is not available on this site.
08/28/2000	SUPPL-16	Supplement	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020168_S016&020656_S005_NUTROPIN FOR INJ.pdf
11/03/1999	SUPPL-15	Supplement		Label is not available on this site.
09/25/1998	SUPPL-14	Supplement		Label is not available on this site.
09/25/1998	SUPPL-13	Supplement		Label is not available on this site.
09/12/1997	SUPPL-12	Supplement		Label is not available on this site.
08/07/1996	SUPPL-11	Supplement		Label is not available on this site.
08/21/1995	SUPPL-10	Supplement		Label is not available on this site.
02/01/1996	SUPPL-9	Supplement		Label is not available on this site.
04/05/1996	SUPPL-8	Supplement		Label is not available on this site.
09/22/1995	SUPPL-7	Supplement		Label is not available on this site.
08/25/1995	SUPPL-6	Supplement		Label is not available on this site.
08/03/1994	SUPPL-5	Supplement		Label is not available on this site.
07/21/1994	SUPPL-4	Supplement		Label is not available on this site.
04/15/1994	SUPPL-3	Supplement		Label is not available on this site.
04/15/1994	SUPPL-2	Supplement		Label is not available on this site.
03/15/1994	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 020168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf

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