APPLICATION
ANDA071696
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-09
LATEST ACTION
2008-01-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2008-01-11Labeling · Supplement 36AP
2001-11-02Manufacturing (CMC) · Supplement 26AP
2001-07-03Labeling · Supplement 25AP
2000-05-01Manufacturing (CMC) · Supplement 24AP
2000-03-20Manufacturing (CMC) · Supplement 22AP
2000-03-20Manufacturing (CMC) · Supplement 23AP
1999-08-31Labeling · Supplement 20AP
1999-04-22Manufacturing (CMC) · Supplement 21AP
1998-07-01Manufacturing (CMC) · Supplement 19AP
1998-05-18Manufacturing (CMC) · Supplement 18AP
1998-05-04Labeling · Supplement 16AP
1998-05-04Labeling · Supplement 14AP
1997-06-27Manufacturing (CMC) · Supplement 17AP
1997-03-06Labeling · Supplement 13AP
1997-02-10Manufacturing (CMC) · Supplement 15AP
1996-01-18Manufacturing (CMC) · Supplement 12AP
1990-11-19Labeling · Supplement 11AP
1990-09-13Labeling · Supplement 10AP
1990-03-02Labeling · Supplement 9AP
1989-08-31Labeling · Supplement 7AP
1989-05-17Bioequivalence · Supplement 5AP
1988-09-28Manufacturing (CMC) · Supplement 3AP
1988-05-04Manufacturing (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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