APPLICATION
ANDA070541
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-17
LATEST ACTION
2024-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EPITOLPrescription
CARBAMAZEPINE 200MG · TABLET · ORAL
Approval history
2024-07-22Labeling · Supplement 72 · standardAP
2022-11-21Labeling · Supplement 71 · standardAP
2020-02-27Labeling · Supplement 60 · standardAP
2020-02-27Labeling · Supplement 64 · standardAP
2015-01-20Labeling · Supplement 57 · standardAP
2015-01-20Labeling · Supplement 58 · standardAP
2014-03-10Labeling · Supplement 54 · standardAP
2014-03-10Labeling · Supplement 55 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 49AP
2012-07-19Labeling · Supplement 53 · standardAP
2011-05-31Labeling · Supplement 52AP
2009-11-04Labeling · Supplement 47AP
2008-03-17Labeling · Supplement 46AP
2002-12-05Labeling · Supplement 45AP
2002-08-01Manufacturing (CMC) · Supplement 42AP
2002-08-01Manufacturing (CMC) · Supplement 43AP
2002-05-08Labeling · Supplement 44AP
2000-05-01Manufacturing (CMC) · Supplement 41AP
1999-12-02Manufacturing (CMC) · Supplement 40AP
1999-12-02Manufacturing (CMC) · Supplement 39AP
1999-08-13Labeling · Supplement 32AP
1999-03-12Manufacturing (CMC) · Supplement 29AP
1999-02-12Manufacturing (CMC) · Supplement 30AP
1999-02-12Manufacturing (CMC) · Supplement 31AP
1998-06-15Manufacturing (CMC) · Supplement 27AP
1997-09-24Labeling · Supplement 28AP
1997-09-24Labeling · Supplement 25AP
1997-05-01Labeling · Supplement 26AP
1997-01-23Manufacturing (CMC) · Supplement 24AP
1996-08-16Manufacturing (CMC) · Supplement 23AP
1996-07-25Manufacturing (CMC) · Supplement 22AP
1995-02-09Labeling · Supplement 21AP
1993-02-18Labeling · Supplement 19AP
1992-01-23Manufacturing (CMC) · Supplement 18AP
1992-01-23Manufacturing (CMC) · Supplement 8AP
1991-12-05Manufacturing (CMC) · Supplement 13AP
1990-11-30Labeling · Supplement 75AP
1990-11-30Labeling · Supplement 17AP
1990-01-19Labeling · Supplement 16AP
1989-08-09Labeling · Supplement 12AP
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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