APPLICATION
NDA006536
TYPE
NDA
ORIGINAL APPROVAL
1948-10-12
LATEST ACTION
1998-04-02
ROUTE
ORAL, INJECTION
DOSAGE FORM
TABLET, INJECTABLE
MARKETING STATUS
Discontinued
Products
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1998-04-02Labeling · Supplement 38 · standardAP
1998-03-31Manufacturing (CMC) · Supplement 42AP
1998-01-20Manufacturing (CMC) · Supplement 43AP
1997-08-14Manufacturing (CMC) · Supplement 41AP
1996-09-03Manufacturing (CMC) · Supplement 40AP
1996-03-11Manufacturing (CMC) · Supplement 39AP
1995-09-11Manufacturing (CMC) · Supplement 37AP
1993-08-09Labeling · Supplement 36AP
1992-08-28Manufacturing (CMC) · Supplement 35AP
1987-03-09Labeling · Supplement 34AP
1985-09-12Manufacturing (CMC) · Supplement 33AP
1985-07-03Manufacturing (CMC) · Supplement 32AP
1985-01-14Labeling · Supplement 28AP
1984-10-24Manufacturing (CMC) · Supplement 30AP
1984-10-11Manufacturing (CMC) · Supplement 31AP
1983-09-16Manufacturing (CMC) · Supplement 29AP
1981-11-03Manufacturing (CMC) · Supplement 26AP
1981-07-14Manufacturing (CMC) · Supplement 27AP
1981-06-17Manufacturing (CMC) · Supplement 25AP
1980-12-22Manufacturing (CMC) · Supplement 24AP
1980-06-24Labeling · Supplement 21AP
1980-05-29Manufacturing (CMC) · Supplement 22AP
1980-05-01Labeling · Supplement 17AP
1980-05-01Labeling · Supplement 23AP
1980-05-01Labeling · Supplement 18AP
1979-08-13Labeling · Supplement 20AP
1978-10-02Labeling · Supplement 16AP
1977-12-12Manufacturing (CMC) · Supplement 15AP
1977-09-19Labeling · Supplement 14AP
1976-05-17Labeling · Supplement 13AP
1976-05-17Manufacturing (CMC) · Supplement 12AP
1948-10-12UNKNOWN · Original · unknownAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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