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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019193
Company: METHAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVOCHOLINE METHACHOLINE CHLORIDE 100MG/VIAL FOR SOLUTION;INHALATION Prescription None Yes Yes
PROVOCHOLINE METHACHOLINE CHLORIDE 1600MG/VIAL FOR SOLUTION;INHALATION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2022 SUPPL-26 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019193s026lbl.pdf
11/10/2020 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019193s024lbl.pdf
11/08/2019 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019193s021lbl.pdf
08/29/2016 SUPPL-17 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019193s017lbl.pdf
07/28/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf
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