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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074943
Company: APOTEX

Products on ANDA 074943

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	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074943

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.

Labels for ANDA 074943

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

Therapeutic Equivalents for ANDA 074943

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	206997	ACCORD HLTHCARE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216304	AMTA
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	206997	ACCORD HLTHCARE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216304	AMTA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	074943	APOTEX

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	206997	ACCORD HLTHCARE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	216304	AMTA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB2	074943	APOTEX

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