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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020414
Company: US ARMY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 30MG TABLET;ORAL 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
02/05/2003 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20414_pyridostigminebromide_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20414ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20414_pyridostigmine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2015 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020414Orig1s004.pdf
09/30/2014 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020414Orig1s003.pdf
01/03/2014 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020414Orig1s002.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/05/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20414_pyridostigminebromide_lbl.pdf
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