Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020392
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYSTAGON CYSTEAMINE BITARTRATE EQ 50MG BASE CAPSULE;ORAL Prescription None Yes No
CYSTAGON CYSTEAMINE BITARTRATE EQ 150MG BASE CAPSULE;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
08/15/1994 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; 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
06/06/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/15/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/06/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020392s010ltr.pdf
01/30/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20392slr007ltr.pdf
04/06/2001 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20392S5ltr.pdf
03/05/1999 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/12/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1996 SUPPL-2 Labeling

Label is not available on this site.

11/28/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf

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