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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103532
Company: GENENTECH

Products on BLA 103532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PULMOZYME	DORNASE ALFA	1MG/ML	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1993	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
02/09/2024	SUPPL-5194	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103532s5194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103532Orig1s5194ltr.pdf
07/30/2021	SUPPL-5191	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103532s5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103532Orig1s5191ltr.pdf
12/12/2014	SUPPL-5175	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103532s5175lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103532Orig1s5175ltr.pdf
10/06/2010	SUPPL-5142	Supplement		Label is not available on this site.
12/20/1999	SUPPL-1030	Supplement		Label is not available on this site.
02/24/1998	SUPPL-1025	Supplement		Label is not available on this site.
11/27/1996	SUPPL-1018	Supplement		Label is not available on this site.

Labels for BLA 103532

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2024	SUPPL-5194	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103532s5194lbl.pdf
07/30/2021	SUPPL-5191	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103532s5191lbl.pdf
12/12/2014	SUPPL-5175	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103532s5175lbl.pdf

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