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FDA ANDA · ANDA071940

CARBAMAZEPINE

Sponsor: JUBILANT CADISTA

APPLICATION
ANDA071940
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-01
LATEST ACTION
1997-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

CARBAMAZEPINEDiscontinued
CARBAMAZEPINE 100MG · TABLET, CHEWABLE · ORAL

Approval history

1997-06-18Labeling · Supplement 13AP
1994-06-23Manufacturing (CMC) · Supplement 11AP
1994-03-08Manufacturing (CMC) · Supplement 8AP
1994-01-07Manufacturing (CMC) · Supplement 10AP
1994-01-07Manufacturing (CMC) · Supplement 9AP
1993-08-31Labeling · Supplement 7AP
1991-03-29Labeling · Supplement 6AP
1990-01-03Labeling · Supplement 19AP
1990-01-03Labeling · Supplement 4AP
1989-03-10Manufacturing (CMC) · Supplement 1AP
1988-02-01Original — Healthcare Professional Sheet ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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