APPLICATION
NDA017744
TYPE
NDA
ORIGINAL APPROVAL
1978-07-14
LATEST ACTION
2017-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
MOTOFEN HALF-STRENGTHDiscontinued
ATROPINE SULFATE 0.025MG, DIFENOXIN HYDROCHLORIDE 0.5MG · TABLET · ORAL
MOTOFEN · ReferencePrescription
ATROPINE SULFATE 0.025MG, DIFENOXIN HYDROCHLORIDE 1MG · TABLET · ORAL
Approval history
2001-12-17Manufacturing (CMC) · Supplement 23 · standardAP
2001-08-17Manufacturing (CMC) · Supplement 22 · standardAP
2001-05-25Manufacturing (CMC) · Supplement 21 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 20 · standardAP
1999-01-07Manufacturing (CMC) · Supplement 19 · standardAP
1999-01-07Manufacturing (CMC) · Supplement 18 · standardAP
1998-10-08Manufacturing (CMC) · Supplement 17 · standardAP
1997-08-13Manufacturing (CMC) · Supplement 15 · standardAP
1997-01-27Manufacturing (CMC) · Supplement 16 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 13 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-19Manufacturing (CMC) · Supplement 14 · standardAP
1992-04-29Labeling · Supplement 10AP
1991-12-03Labeling · Supplement 5AP
1991-01-29Manufacturing (CMC) · Supplement 6 · standardAP
1988-08-19Manufacturing (CMC) · Supplement 4 · standardAP
1988-07-20Labeling · Supplement 3AP
1982-04-21Labeling · Supplement 2AP
1981-12-28Labeling · Supplement 1AP
1978-07-14Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standardAP
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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