Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021392
Company: BAUSCH
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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS 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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS 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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS 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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS 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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS 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 |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS INC |