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FDA ANDA · ANDA088763
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Sponsor: ACTAVIS MID ATLANTIC
APPLICATION
ANDA088763
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-31
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE · ReferenceDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL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
2025-12-23Labeling · Supplement 91 · standardAP
2023-12-15Labeling · Supplement 90 · standardAP
2018-06-28Labeling · Supplement 89 · standardAP
2018-06-19Labeling · Supplement 88 · standardAP
2017-08-29Labeling · Supplement 87 · standardAP
2017-01-13Labeling · Supplement 86 · standardAP
2014-02-19Labeling · Supplement 83 · standardAP
2009-08-27Labeling · Supplement 78AP
2008-12-19Labeling · Supplement 74AP
2005-10-06Labeling · Supplement 60AP
2005-05-02Labeling · Supplement 54AP
2003-06-06Labeling · Supplement 47AP
2001-10-03Manufacturing (CMC) · Supplement 46AP
2001-10-03Manufacturing (CMC) · Supplement 45AP
2000-10-02Manufacturing (CMC) · Supplement 44AP
1998-12-01Manufacturing (CMC) · Supplement 40AP
1998-12-01Manufacturing (CMC) · Supplement 39AP
1997-09-15Manufacturing (CMC) · Supplement 37AP
1996-10-21Manufacturing (CMC) · Supplement 36AP
1996-06-18Manufacturing (CMC) · Supplement 35AP
1996-05-30Manufacturing (CMC) · Supplement 26AP
1996-05-30Manufacturing (CMC) · Supplement 27AP
1996-05-07Manufacturing (CMC) · Supplement 28AP
1996-05-07Manufacturing (CMC) · Supplement 32AP
1996-05-07Manufacturing (CMC) · Supplement 29AP
1996-05-07Labeling · Supplement 33AP
1996-05-07Manufacturing (CMC) · Supplement 31AP
1995-10-23Manufacturing (CMC) · Supplement 30AP
1994-04-29Manufacturing (CMC) · Supplement 25AP
1993-08-03Manufacturing (CMC) · Supplement 23AP
1993-04-05Manufacturing (CMC) · Supplement 22AP
1990-09-28Manufacturing (CMC) · Supplement 21AP
1990-08-24Labeling · Supplement 19AP
1989-11-03Labeling · Supplement 18AP
1989-06-21Manufacturing (CMC) · Supplement 15AP
1989-06-21Manufacturing (CMC) · Supplement 16AP
1989-06-21Manufacturing (CMC) · Supplement 14AP
1988-12-15Manufacturing (CMC) · Supplement 13AP
1988-12-15Manufacturing (CMC) · Supplement 12AP
1987-10-13Manufacturing (CMC) · Supplement 4AP
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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