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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021175
Company: US ARMY

Products on NDA 021175

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATNAA	ATROPINE; PRALIDOXIME CHLORIDE	2.1MG/0.7ML;600MG/2ML	INJECTABLE;INTRAMUSCULAR	Discontinued	None	No	No

Showing 1 to 1 of 1 entries

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021175

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
01/17/2002	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review

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Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/26/2022	SUPPL-47	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)
05/22/2020	SUPPL-41	Labeling-Package Insert	Label (PDF) Letter (PDF)
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.
03/02/2016	SUPPL-27	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.
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.

Showing 1 to 12 of 12 entries

Labels for NDA 021175

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/26/2022	SUPPL-47	Labeling-Container/Carton Labels	Label (PDF)
05/26/2022	SUPPL-47	Labeling-Package Insert	Label (PDF)
05/22/2020	SUPPL-41	Labeling-Package Insert	Label (PDF)
01/17/2002	ORIG-1	Approval	Label (PDF)

Showing 1 to 4 of 4 entries

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