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FDA ANDA · ANDA074051

DILTIAZEM HYDROCHLORIDE

Sponsor: APOTHECON

APPLICATION
ANDA074051
TYPE
ANDA
ORIGINAL APPROVAL
1993-03-31
LATEST ACTION
1997-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 30MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG · TABLET · ORAL

Approval history

1997-09-24Labeling · Supplement 9AP
1997-06-27Labeling · Supplement 8AP
1996-08-26Manufacturing (CMC) · Supplement 7AP
1995-12-08Manufacturing (CMC) · Supplement 6AP
1995-12-08Manufacturing (CMC) · Supplement 4AP
1995-12-08Manufacturing (CMC) · Supplement 5AP
1995-01-19Labeling · Supplement 3AP
1994-09-22Manufacturing (CMC) · Supplement 2AP
1993-09-09Manufacturing (CMC) · Supplement 1AP
1993-03-31OriginalAP
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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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