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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021983
Company: MMT

Products on NDA 021983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUODOTE	ATROPINE; PRALIDOXIME CHLORIDE	2.1MG/0.7ML;600MG/2ML	INJECTABLE;INTRAMUSCULAR	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021983s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021983_duodote_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2022	SUPPL-38	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021983Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021983Orig1s038ltr.pdf
10/06/2017	SUPPL-23	Efficacy-New Patient Population, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021983Orig1s023ltr.pdf
11/03/2016	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/08/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/25/2016	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/11/2015	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/02/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/22/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/21/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/09/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021983

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2022	SUPPL-38	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021983Orig1s038lbl.pdf
05/17/2022	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021983Orig1s038lbl.pdf
10/06/2017	SUPPL-23	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf
10/06/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021983s023lbl.pdf

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