Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020027
Company: BIOVAIL LABS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIZEM DILTIAZEM HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CARDIZEM DILTIAZEM HYDROCHLORIDE 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/24/1991 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-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/2004 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20027s019ltr.pdf
02/05/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/20/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/28/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1996 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/02/1996 SUPPL-11 Labeling

Label is not available on this site.

01/04/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1996 SUPPL-9 Labeling

Label is not available on this site.

10/24/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/28/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/15/1994 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1993 SUPPL-3 Labeling

Label is not available on this site.

05/24/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/01/1992 SUPPL-1 Labeling

Label is not available on this site.

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