Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202463
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/07/2012 ORIG-1 Approval

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 202463 ACTAVIS ELIZABETH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

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