Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103532
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PULMOZYME DORNASE ALFA 1MG/ML VIAL Prescription None No No
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2014 SUPPL-5175 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103532s5175lbl.pdf

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