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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021749
Company: HAMELN

Other Important Information from FDA

Questions and Answers

Products on NDA 021749

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTETATE CALCIUM TRISODIUM	PENTETATE CALCIUM TRISODIUM	EQ 1GM BASE/5ML (EQ 200MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INHALATION, INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021749lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-749_21-751_Pentetate.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/16/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/21/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021749s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021749Orig1s008ltr.pdf
08/04/2005	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf

Labels for NDA 021749

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021749s008lbl.pdf
08/11/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021749lbl.pdf

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