APPLICATION
ANDA085311
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-07
LATEST ACTION
2000-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LONOXDiscontinued
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
2000-11-28Manufacturing (CMC) · Supplement 72AP
2000-08-24Manufacturing (CMC) · Supplement 71AP
1999-08-04Labeling · Supplement 67AP
1999-08-04Manufacturing (CMC) · Supplement 66AP
1999-05-05Manufacturing (CMC) · Supplement 69AP
1998-11-23Manufacturing (CMC) · Supplement 68AP
1998-06-08Manufacturing (CMC) · Supplement 65AP
1998-01-29Manufacturing (CMC) · Supplement 64AP
1991-06-26Labeling · Supplement 63AP
1989-12-19Labeling · Supplement 62AP
1989-08-09Labeling · Supplement 61AP
1988-12-09Labeling · Supplement 60AP
1988-04-19Labeling · Supplement 59AP
1985-10-28Manufacturing (CMC) · Supplement 52AP
1985-01-23Manufacturing (CMC) · Supplement 53AP
1983-06-17Manufacturing (CMC) · Supplement 51AP
1983-04-22Manufacturing (CMC) · Supplement 49AP
1983-04-22Manufacturing (CMC) · Supplement 50AP
1982-11-16Manufacturing (CMC) · Supplement 47AP
1982-10-15Manufacturing (CMC) · Supplement 46AP
1982-07-29Manufacturing (CMC) · Supplement 43AP
1982-07-29Manufacturing (CMC) · Supplement 44AP
1982-05-13Manufacturing (CMC) · Supplement 40AP
1982-05-13Manufacturing (CMC) · Supplement 39AP
1982-05-13Manufacturing (CMC) · Supplement 38AP
1977-06-07OriginalAP
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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