Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2019 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019193s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019193Orig1s021ltr.pdf
08/29/2016 SUPPL-17 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019193s017lbl.pdf
07/28/2008 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019193s013ltr.pdf
03/08/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/21/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/14/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1988 SUPPL-2 Labeling

Label is not available on this site.

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