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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020392
Company: MYLAN

Products on NDA 020392

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020392

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.

Labels for NDA 020392

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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