APPLICATION
ANDA088761
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-08
LATEST ACTION
2011-08-01
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETH VC PLAIN · ReferenceDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2011-08-01Labeling · Supplement 78AP
2005-10-06Labeling · Supplement 64AP
2005-05-02Labeling · Supplement 55AP
2003-06-06Labeling · Supplement 49AP
2001-10-03Manufacturing (CMC) · Supplement 48AP
2001-10-03Manufacturing (CMC) · Supplement 47AP
2000-10-02Manufacturing (CMC) · Supplement 46AP
1998-12-01Manufacturing (CMC) · Supplement 42AP
1998-12-01Manufacturing (CMC) · Supplement 41AP
1997-09-02Manufacturing (CMC) · Supplement 39AP
1996-11-08Manufacturing (CMC) · Supplement 38AP
1996-06-18Manufacturing (CMC) · Supplement 37AP
1996-05-30Manufacturing (CMC) · Supplement 28AP
1996-05-30Manufacturing (CMC) · Supplement 29AP
1996-05-07Manufacturing (CMC) · Supplement 31AP
1996-05-07Manufacturing (CMC) · Supplement 34AP
1996-05-07Manufacturing (CMC) · Supplement 30AP
1996-05-07Labeling · Supplement 35AP
1996-05-07Manufacturing (CMC) · Supplement 33AP
1995-10-23Manufacturing (CMC) · Supplement 32AP
1994-02-02Manufacturing (CMC) · Supplement 27AP
1991-09-27Manufacturing (CMC) · Supplement 26AP
1991-04-23Manufacturing (CMC) · Supplement 25AP
1991-01-23Manufacturing (CMC) · Supplement 23AP
1990-12-06Manufacturing (CMC) · Supplement 22AP
1990-09-28Manufacturing (CMC) · Supplement 24AP
1990-06-01Labeling · Supplement 21AP
1990-05-25Manufacturing (CMC) · Supplement 17AP
1990-05-25Manufacturing (CMC) · Supplement 18AP
1990-05-25Manufacturing (CMC) · Supplement 16AP
1989-12-22Labeling · Supplement 20AP
1988-12-15Manufacturing (CMC) · Supplement 15AP
1988-12-15Manufacturing (CMC) · Supplement 14AP
1987-10-13Manufacturing (CMC) · Supplement 4AP
1987-10-13Manufacturing (CMC) · Supplement 3AP
1987-03-18Manufacturing (CMC) · Supplement 5AP
1987-03-17Manufacturing (CMC) · Supplement 10AP
1986-02-18Manufacturing (CMC) · Supplement 8AP
1986-02-18Manufacturing (CMC) · Supplement 7AP
1985-08-14Manufacturing (CMC) · Supplement 2AP
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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