Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020772
Company: QOL MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUCRAID SACROSIDASE 8,500 IU/ML SOLUTION;ORAL 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
04/09/1998 ORIG-1 Approval N/A; Orphan Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20772ap_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20772.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2015 SUPPL-20 Supplement

Label is not available on this site.

02/16/2015 SUPPL-19 Supplement

Label is not available on this site.

12/02/2014 SUPPL-17 Supplement

Label is not available on this site.

11/07/2014 SUPPL-15 Supplement

Label is not available on this site.

05/28/2013 SUPPL-13 Supplement

Label is not available on this site.

12/09/2010 SUPPL-11 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020772s011ltr.pdf
06/15/2011 SUPPL-8 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020772s008ltr.pdf
11/20/2008 SUPPL-7 Supplement

Label is not available on this site.

11/20/2008 SUPPL-6 Supplement

Label is not available on this site.

11/20/2008 SUPPL-5 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020772s005ltr.pdf
02/20/2008 SUPPL-4 Supplement

Label is not available on this site.

11/03/2006 SUPPL-2 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020772s002ltr.pdf

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