Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019193
Company: METHAPHARM
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 |