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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017106
Company: MMT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPEN ATROPINE EQ 2MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Discontinued None Yes No
ATROPEN ATROPINE EQ 1MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Discontinued None Yes No
ATROPEN ATROPINE EQ 0.5MG SULFATE/0.7ML SOLUTION;INTRAMUSCULAR Discontinued None Yes No
ATROPEN ATROPINE EQ 0.25MG SULFATE/0.3ML SOLUTION;INTRAMUSCULAR Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/20/2020 SUPPL-52 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017106s052lbl.pdf
11/20/2020 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017106s052lbl.pdf
09/17/2004 SUPPL-32 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf
06/19/2003 SUPPL-28 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf
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