Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074852
Company: ACTAVIS LABS FL INC

Products on ANDA 074852

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074852

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2007	SUPPL-14	Labeling		Label is not available on this site.
03/12/2007	SUPPL-13	Labeling		Label is not available on this site.
12/24/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
10/11/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
02/15/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/16/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/07/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.