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FDA ANDA · ANDA085272

BONTRIL PDM

Sponsor: BAUSCH

APPLICATION
ANDA085272
TYPE
ANDA
ORIGINAL APPROVAL
1976-12-22
LATEST ACTION
2008-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BONTRIL PDM · ReferencePrescription
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL

Approval history

2008-01-16Labeling · Supplement 44AP
2001-12-06Manufacturing (CMC) · Supplement 41AP
2001-08-15Manufacturing (CMC) · Supplement 40AP
2000-08-29Manufacturing (CMC) · Supplement 39AP
1997-06-27Manufacturing (CMC) · Supplement 38AP
1994-09-29Manufacturing (CMC) · Supplement 37AP
1991-12-04Labeling · Supplement 36AP
1991-11-18Manufacturing (CMC) · Supplement 35AP
1991-04-26Labeling · Supplement 34AP
1990-07-18Manufacturing (CMC) · Supplement 33AP
1990-07-18Manufacturing (CMC) · Supplement 32AP
1988-10-05Manufacturing (CMC) · Supplement 31AP
1988-10-05Manufacturing (CMC) · Supplement 30AP
1988-01-20Manufacturing (CMC) · Supplement 29AP
1985-07-17Manufacturing (CMC) · Supplement 27AP
1985-07-17Manufacturing (CMC) · Supplement 26AP
1985-07-17Manufacturing (CMC) · Supplement 24AP
1984-10-11Manufacturing (CMC) · Supplement 23AP
1983-08-16Manufacturing (CMC) · Supplement 22AP
1983-05-18Manufacturing (CMC) · Supplement 21AP
1976-12-22OriginalAP
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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