APPLICATION
ANDA088762
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-31
LATEST ACTION
2015-11-02
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETH W/ DEXTROMETHORPHANDiscontinued
DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
2015-11-02Labeling · Supplement 74AP
2005-12-05Labeling · Supplement 60AP
2005-05-02Labeling · Supplement 55AP
2003-06-06Labeling · Supplement 52AP
2001-10-03Manufacturing (CMC) · Supplement 51AP
2001-10-03Manufacturing (CMC) · Supplement 50AP
2000-10-02Manufacturing (CMC) · Supplement 49AP
2000-08-01Manufacturing (CMC) · Supplement 45AP
2000-08-01Manufacturing (CMC) · Supplement 46AP
1998-12-01Manufacturing (CMC) · Supplement 43AP
1998-12-01Manufacturing (CMC) · Supplement 44AP
1997-09-22Manufacturing (CMC) · Supplement 41AP
1996-10-18Labeling · Supplement 40AP
1996-06-18Manufacturing (CMC) · Supplement 39AP
1996-05-30Manufacturing (CMC) · Supplement 30AP
1996-05-30Manufacturing (CMC) · Supplement 31AP
1996-05-07Labeling · Supplement 37AP
1996-05-07Manufacturing (CMC) · Supplement 35AP
1996-05-07Manufacturing (CMC) · Supplement 33AP
1996-05-07Manufacturing (CMC) · Supplement 36AP
1996-05-07Manufacturing (CMC) · Supplement 32AP
1995-10-23Manufacturing (CMC) · Supplement 34AP
1994-02-02Manufacturing (CMC) · Supplement 29AP
1993-06-04Manufacturing (CMC) · Supplement 28AP
1992-04-14Manufacturing (CMC) · Supplement 27AP
1991-04-23Manufacturing (CMC) · Supplement 26AP
1991-02-22Labeling · Supplement 21AP
1991-01-23Manufacturing (CMC) · Supplement 24AP
1991-01-23Manufacturing (CMC) · Supplement 25AP
1990-10-03Manufacturing (CMC) · Supplement 16AP
1990-10-03Manufacturing (CMC) · Supplement 19AP
1990-10-03Manufacturing (CMC) · Supplement 15AP
1990-10-03Manufacturing (CMC) · Supplement 18AP
1990-09-28Manufacturing (CMC) · Supplement 22AP
1990-03-26Labeling · Supplement 20AP
1989-12-19Labeling · Supplement 14AP
1989-05-31Manufacturing (CMC) · Supplement 10AP
1989-05-31Manufacturing (CMC) · Supplement 11AP
1988-12-15Manufacturing (CMC) · Supplement 8AP
1988-12-15Manufacturing (CMC) · Supplement 9AP
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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