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FDA ANDA · ANDA088440

URECHOLINE

Sponsor: ODYSSEY PHARMS

APPLICATION
ANDA088440
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-29
LATEST ACTION
2002-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 10MG · TABLET · ORAL

Approval history

2002-03-12Labeling · Supplement 16AP
2002-03-12Manufacturing (CMC) · Supplement 15AP
2001-10-25Manufacturing (CMC) · Supplement 13AP
2001-10-12Manufacturing (CMC) · Supplement 14AP
2000-10-25Manufacturing (CMC) · Supplement 12AP
2000-10-02Manufacturing (CMC) · Supplement 11AP
1996-05-22Labeling · Supplement 10AP
1994-05-11Manufacturing (CMC) · Supplement 9AP
1992-05-14Labeling · Supplement 8AP
1992-02-28Labeling · Supplement 7AP
1991-03-25Labeling · Supplement 6AP
1988-07-08Manufacturing (CMC) · Supplement 5AP
1986-06-30Manufacturing (CMC) · Supplement 2AP
1986-05-15Manufacturing (CMC) · Supplement 3AP
1984-05-29OriginalAP
VIEW ON DRUGS@FDA ↗

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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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