Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020576
Company: RECORDATI RARE

Products on NDA 20576

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYSTADANE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020576

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