Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074752
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARTIA XT | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| CARTIA XT | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| CARTIA XT | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| CARTIA XT | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/09/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/74752lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74752ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074752.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/24/2026 | SUPPL-56 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/24/2026 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2026 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2011 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/04/2006 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/18/2003 | SUPPL-18 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF | |
| 12/24/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 10/11/2002 | SUPPL-16 | Manufacturing (CMC)-Facility |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 02/27/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 01/08/2001 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 01/08/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 08/16/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 05/12/2000 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 07/18/2000 | SUPPL-8 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 04/02/1999 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-3 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| 06/08/1999 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074752_S001_thru_S018.PDF |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/09/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/74752lbl.pdf |
CARTIA XT
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 | 216968 | ALEMBIC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 218744 | MACLEODS PHARMS LTD |
| 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 | PH HEALTH |
| 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; 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 | 216968 | ALEMBIC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 218744 | MACLEODS PHARMS LTD |
| 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 | PH HEALTH |
| 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; 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 | 216968 | ALEMBIC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 218744 | MACLEODS PHARMS LTD |
| 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 | PH HEALTH |
| 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 | 216968 | ALEMBIC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 218744 | MACLEODS PHARMS LTD |
| 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 | PH HEALTH |
| 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 |