Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021751
Company: HAMELN PHARMA PLUS

Products on NDA 021751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTETATE ZINC TRISODIUM	PENTETATE ZINC TRISODIUM	EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INHALATION, INTRAVENOUS	Discontinued	None	Yes	No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 021751

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/2004/021751lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-751_21-749_Pentetate.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2013	SUPPL-8	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021751Orig1s008ltr.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 021751

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2013	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf
08/11/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021751lbl.pdf