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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020576

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020576

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.

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

Therapeutic Equivalents for NDA 020576

CYSTADANE

FOR SOLUTION;ORAL; 1GM/SCOOPFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	No	AB	210508	ETON
BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	No	AB	214864	NOVITIUM PHARMA
CYSTADANE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION;ORAL	Prescription	Yes	AB	020576	RECORDATI RARE

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