Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021175
Company: US ARMY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATNAA ATROPINE; PRALIDOXIME CHLORIDE 2.1MG/0.7ML;600MG/0.7ML INJECTABLE;INTRAMUSCULAR 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
01/17/2002 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/27/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/25/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/11/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/22/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/02/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/15/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/10/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf

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