APPLICATION
ANDA088764
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-31
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETH VC W/ CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-22Labeling · Supplement 90 · standardAP
2023-12-15Labeling · Supplement 89 · standardAP
2018-06-28Labeling · Supplement 88 · standardAP
2018-06-08Labeling · Supplement 87 · standardAP
2017-08-29Labeling · Supplement 86 · standardAP
2017-01-13Labeling · Supplement 85 · standardAP
2013-05-03Labeling · Supplement 81AP
2011-08-01Labeling · Supplement 75AP
2009-03-20Labeling · Supplement 77AP
2005-10-06Labeling · Supplement 63AP
2005-05-02Labeling · Supplement 53AP
2003-06-06Labeling · Supplement 49AP
2002-07-15Manufacturing (CMC) · Supplement 48AP
2001-10-03Manufacturing (CMC) · Supplement 47AP
2001-10-03Manufacturing (CMC) · Supplement 46AP
2000-10-02Manufacturing (CMC) · Supplement 45AP
1998-12-01Manufacturing (CMC) · Supplement 42AP
1998-11-05Manufacturing (CMC) · Supplement 39AP
1998-11-05Manufacturing (CMC) · Supplement 41AP
1998-11-05Manufacturing (CMC) · Supplement 40AP
1997-09-02Manufacturing (CMC) · Supplement 37AP
1997-04-07Manufacturing (CMC) · Supplement 36AP
1996-06-18Manufacturing (CMC) · Supplement 35AP
1996-05-30Manufacturing (CMC) · Supplement 27AP
1996-05-30Manufacturing (CMC) · Supplement 28AP
1996-05-07Manufacturing (CMC) · Supplement 29AP
1996-05-07Manufacturing (CMC) · Supplement 33AP
1996-05-07Labeling · Supplement 34AP
1996-05-07Manufacturing (CMC) · Supplement 32AP
1996-05-07Manufacturing (CMC) · Supplement 30AP
1995-10-23Manufacturing (CMC) · Supplement 31AP
1994-02-02Manufacturing (CMC) · Supplement 26AP
1992-06-12Labeling · Supplement 25AP
1991-02-08Labeling · Supplement 21AP
1991-01-23Manufacturing (CMC) · Supplement 23AP
1990-10-03Manufacturing (CMC) · Supplement 17AP
1990-10-03Manufacturing (CMC) · Supplement 15AP
1990-10-03Manufacturing (CMC) · Supplement 16AP
1990-09-28Manufacturing (CMC) · Supplement 22AP
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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