Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020062
Company: BAUSCH
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 |
|---|---|---|---|---|---|
| 03/26/2020 | SUPPL-46 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020062s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020062Orig1s046ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/26/2020 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020062s046lbl.pdf | |
| 03/26/2020 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020062s046lbl.pdf | |
| 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 | 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 | 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 | 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 | 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 | 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 |