APPLICATION
ANDA085266
TYPE
ANDA
ORIGINAL APPROVAL
1977-04-18
LATEST ACTION
1992-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DI-ATRODiscontinued
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
1992-03-30Labeling · Supplement 71AP
1989-04-05Labeling · Supplement 70AP
1988-10-18Labeling · Supplement 69AP
1988-05-25Labeling · Supplement 68AP
1977-04-18OriginalAP
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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