Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018602
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIZEM DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB Yes No
CARDIZEM DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB Yes No
CARDIZEM DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription AB Yes No
CARDIZEM DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/05/1982 ORIG-1 Approval Type 1 - New Molecular Entity 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
11/18/2016 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018602s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018602Orig1s067ltr.pdf
11/21/2014 SUPPL-65 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf
06/24/2014 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

11/23/2010 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018602s063ltr.pdf
06/04/2001 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1999 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2003 SUPPL-56 Labeling

Label is not available on this site.

02/05/1998 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

11/19/1997 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1997 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1996 SUPPL-51 Labeling

Label is not available on this site.

04/02/1996 SUPPL-50 Labeling

Label is not available on this site.

08/29/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1994 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1994 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1995 SUPPL-46 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/21/1994 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/28/1994 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/1993 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1993 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1994 SUPPL-40 Labeling

Label is not available on this site.

05/27/1992 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1991 SUPPL-38 Labeling

Label is not available on this site.

03/14/1991 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/18/1989 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/1989 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1990 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1988 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1988 SUPPL-32 Labeling

Label is not available on this site.

08/12/1988 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1988 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/19/1988 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/30/1987 SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/07/1987 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987 SUPPL-25 Labeling

Label is not available on this site.

07/01/1993 SUPPL-23 Efficacy-New Indication

Label is not available on this site.

07/28/1986 SUPPL-22 Labeling

Label is not available on this site.

12/08/1986 SUPPL-20 Efficacy-New Patient Population

Label is not available on this site.

06/20/1985 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1986 SUPPL-11 Efficacy-New Dosing Regimen

Label is not available on this site.

06/08/1984 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1984 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/08/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1983 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/06/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/27/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1983 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1983 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2016 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018602s067lbl.pdf
11/21/2014 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf
11/23/2010 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf

CARDIZEM

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 90MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 074185 TEVA

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