Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020062
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB3 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
12/27/1991 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/23/2017 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/18/2016 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020062Orig1s043ltr.pdf
06/29/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020062Orig1s042.pdf
11/22/2010 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020062s040ltr.pdf
06/04/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/2000 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/19/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/29/1999 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1999 SUPPL-27 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20062-s027_cardizem.pdf
04/15/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2003 SUPPL-25 Labeling

Label is not available on this site.

04/07/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1996 SUPPL-21 Labeling

Label is not available on this site.

04/02/1996 SUPPL-19 Labeling

Label is not available on this site.

10/31/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1994 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1995 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/03/1995 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1993 SUPPL-7 Labeling

Label is not available on this site.

06/29/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1993 SUPPL-5 Labeling

Label is not available on this site.

09/18/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/10/1992 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

08/04/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/15/1992 SUPPL-1 Efficacy-New Indication

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-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s043lbl.pdf
06/29/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s042lbl.pdf
11/22/2010 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf

CARDIZEM CD

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
CARTIA XT DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074752 ACTAVIS LABS FL INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074984 PAR PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 075116 VALEANT PHARMS NORTH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
CARTIA XT DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074752 ACTAVIS LABS FL INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074984 PAR PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 075116 VALEANT PHARMS NORTH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
CARTIA XT DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074752 ACTAVIS LABS FL INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074984 PAR PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 075116 VALEANT PHARMS NORTH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
CARTIA XT DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074752 ACTAVIS LABS FL INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 074984 PAR PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 075116 VALEANT PHARMS NORTH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM CD DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB3 020062 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 202463 ACTAVIS ELIZABETH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 208783 NOVAST LABS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 090492 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 203023 SUN PHARM
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 205231 TWI PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB3 206534 ZYDUS PHARMS

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