Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021092
Company: METABOLIC SOLUTIONS

Products on NDA 021092

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HELICOSOL	UREA C-13	125MG/VIAL	FOR SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021092

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1999	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21092ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21092_Helicosol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021092

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21092lbl.pdf