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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021084
Company: US ARMY MED RES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE 50%;50% PASTE;TOPICAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/17/2000 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21084ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21084_SERPACWA.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/17/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21084lbl.pdf
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