Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022562
Company: ORPHAN EUROPE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAGLU CARGLUMIC ACID 200MG TABLET;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
03/18/2010 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022562s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022562s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/23/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022562Orig1s002ltr.pdf
07/22/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf
03/18/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf

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