Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/09/2010 ORIG-11 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

04/09/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; 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 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/02/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/07/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/28/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/15/2011 SUPPL-8 Labeling 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 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2008 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/20/2008 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal 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 Labeling-Container/Carton Labels

Label is not available on this site.

11/03/2006 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

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

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