Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 06/29/2020 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018602Orig1s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018602Orig1s069ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 06/29/2020 | SUPPL-69 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018602Orig1s069lbl.pdf | |
| 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 | 216521 | SCIEGEN PHARMS INC |
| 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 | 216521 | SCIEGEN PHARMS INC |
| 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 | 216521 | SCIEGEN PHARMS INC |
| 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 | 216521 | SCIEGEN PHARMS INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 074185 | TEVA |