Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021392
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;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
02/06/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021392lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-392_CardizemTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021392s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021392Orig1s020ltr.pdf
03/23/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021392s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021392Orig1s019ltr.pdf
11/23/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021392s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021392s014ltr.pdf
04/27/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021392s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021392s010ltr.pdf
04/02/2004 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21392se1-002_cardizem_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21392se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXENTED_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021392s020lbl.pdf
03/23/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021392s019lbl.pdf
11/23/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021392s014lbl.pdf
04/27/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021392s010lbl.pdf
04/02/2004 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21392se1-002_cardizem_lbl.pdf
02/06/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021392lbl.pdf

CARDIZEM LA

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; 420MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM LA DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021392 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077686 ACTAVIS LABS FL INC

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