← FDA DRUG APPROVALS
FDA ANDA · ANDA085035
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Sponsor: R AND S PHARMA
APPLICATION
ANDA085035
TYPE
ANDA
ORIGINAL APPROVAL
1977-07-05
LATEST ACTION
1988-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDiscontinued
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
1988-07-26Manufacturing (CMC) · Supplement 31AP
1988-07-26Manufacturing (CMC) · Supplement 30AP
1988-07-15Bioequivalence · Supplement 1AP
1988-05-04Labeling · Supplement 32AP
1983-08-17Manufacturing (CMC) · Supplement 27AP
1983-08-17Manufacturing (CMC) · Supplement 25AP
1983-08-17Manufacturing (CMC) · Supplement 26AP
1982-12-28Manufacturing (CMC) · Supplement 23AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.