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FDA ANDA · ANDA087708

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: HIKMA

APPLICATION
ANDA087708
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-03
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 0.025MG/5ML, DIPHENOXYLATE HYDROCHLORIDE 2.5MG/5ML · SOLUTION · ORAL

Approval history

2024-11-14Labeling · Supplement 23 · standardAP
2017-05-05Manufacturing (CMC) · Supplement 22 · unknownAP
2008-07-31Labeling · Supplement 21AP
2007-11-16Labeling · Supplement 20AP
2007-03-28Labeling · Supplement 19AP
2001-12-28Manufacturing (CMC) · Supplement 16AP
2001-04-03Manufacturing (CMC) · Supplement 15AP
2001-04-03Manufacturing (CMC) · Supplement 13AP
2001-04-03Manufacturing (CMC) · Supplement 14AP
2001-04-03Manufacturing (CMC) · Supplement 12AP
1999-08-12Manufacturing (CMC) · Supplement 10AP
1998-05-20Labeling · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 8AP
1994-10-06Labeling · Supplement 7AP
1991-06-27Manufacturing (CMC) · Supplement 6AP
1989-06-01Labeling · Supplement 3AP
1988-09-23Bioequivalence · Supplement 1AP
1988-09-15Manufacturing (CMC) · Supplement 4AP
1988-09-15Manufacturing (CMC) · Supplement 5AP
1982-05-03OriginalAP
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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