Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019471
Company: BIOVAIL

Products on NDA 019471

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019471

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2001	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/1999	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
03/21/2003	SUPPL-29	Labeling		Label is not available on this site.
12/03/1998	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
11/20/1997	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
08/05/1997	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/1996	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
05/28/1996	SUPPL-24	Labeling		Label is not available on this site.
03/17/1995	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
09/14/1994	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/14/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/03/1995	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/18/1994	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/15/1994	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
08/02/1993	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-15	Labeling		Label is not available on this site.
10/22/1992	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/1992	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/1991	SUPPL-11	Labeling		Label is not available on this site.
07/01/1992	SUPPL-10	Labeling		Label is not available on this site.
01/07/1991	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/14/1990	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/27/1990	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/16/1990	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/23/1990	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/1989	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.