Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021983
Company: MERIDIAN MEDCL
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English