Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020576
Company: ORPHAN EUROPE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYSTADANE BETAINE 1GM/SCOOPFUL FOR 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
10/25/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020576Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020576s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020576Orig1s014ltr.pdf
04/05/2010 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020576s010ltr.pdf
02/17/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020576s008ltr.pdf
08/25/2000 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/16/1999 SUPPL-3 Labeling

Label is not available on this site.

08/13/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020576s014lbl.pdf
04/05/2010 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf
02/17/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf

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