Application 019193

Type
NDA
Sponsor
METHAPHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PROVOCHOLINEMETHACHOLINE CHLORIDEFOR SOLUTION;INHALATION100MG/VIALYesYes
002PROVOCHOLINEMETHACHOLINE CHLORIDEFOR SOLUTION;INHALATION1600MG/VIALYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-100Provocholinemethacholine chlorideMethapharm Inc.NDACurrent
64281-110Provocholine Inhalation SolutionMethacholine Chloride Inhalation SolutionMethapharm Inc.NDACurrent
64281-110Provocholine Inhalation SolutionMethacholine Chloride Inhalation SolutionMethapharm Inc.NDACurrent

Documents

DocumentSubmission typeDate
70376SUPPL2022-03-02
70358SUPPL2022-03-02
65207SUPPL2020-11-13
65183SUPPL2020-11-12
60824SUPPL2019-11-13
60821SUPPL2019-11-12
45223SUPPL2016-08-29
11448SUPPL2008-08-13
1247SUPPL2008-07-30