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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019193
Company: METHAPHARM

Products on NDA 019193

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019193

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
03/01/2022	SUPPL-26	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019193s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019193Orig1s026ltr.pdf
11/10/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019193s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019193Orig1s024ltr.pdf
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.

Labels for NDA 019193

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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