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FDA ANDA · ANDA074185

DILTIAZEM HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA074185
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-31
LATEST ACTION
2020-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-04-29Labeling · Supplement 21 · standardAP
2020-04-29Labeling · Supplement 18 · standardAP
2011-01-27Labeling · Supplement 16AP
1999-12-02Manufacturing (CMC) · Supplement 11AP
1999-12-02Manufacturing (CMC) · Supplement 12AP
1999-02-12Manufacturing (CMC) · Supplement 5AP
1999-02-12Manufacturing (CMC) · Supplement 4AP
1998-01-08Manufacturing (CMC) · Supplement 3AP
1997-06-06Manufacturing (CMC) · Supplement 2AP
1997-01-24Labeling · Supplement 1AP
1995-05-31OriginalAP
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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