Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074943
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No Yes
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
08/06/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74943_Diltiazem%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74943ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074943_diltiazem_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/20/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/12/2007 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2005 SUPPL-6 Labeling

Label is not available on this site.

03/22/2002 SUPPL-4 Labeling

Label is not available on this site.

03/22/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/19/2000 SUPPL-2 Labeling

Label is not available on this site.

12/19/2000 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74943_Diltiazem%20Hydrochloride_Prntlbl.pdf

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 074943 APOTEX

CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 074943 APOTEX

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