Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076151
Company: APOTEX

Products on ANDA 076151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILT-CD	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILT-CD	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILT-CD	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILT-CD	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2004	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076151_s000_DiltTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.