Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020401
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | Yes | No |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | Yes | No |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | Yes | No |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | Yes | No |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | Yes | No |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 420MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB4 | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 11/18/2016 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020401s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020401Orig1s042ltr.pdf | |
| 11/20/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020401s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020401s036ltr.pdf | |
| 06/21/2007 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020401s034ltr.pdf |
| 10/03/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/2001 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2001 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/2000 | SUPPL-19 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20401-s019_tiazac.pdf |
| 02/17/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-401S013_Tiazac.pdf |
| 01/28/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-7 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020401ap.pdf |
| 10/01/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/18/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020401s042lbl.pdf | |
| 11/22/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020401s036lbl.pdf |
TIAZAC
CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 090421 | SUN PHARM |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 075401 | ACTAVIS LABS FL INC |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |
CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 090421 | SUN PHARM |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 075401 | ACTAVIS LABS FL INC |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |
CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 090421 | SUN PHARM |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 075401 | ACTAVIS LABS FL INC |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |
CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 090421 | SUN PHARM |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 075401 | ACTAVIS LABS FL INC |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |
CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 090421 | SUN PHARM |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 075401 | ACTAVIS LABS FL INC |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |
CAPSULE, EXTENDED RELEASE;ORAL; 420MG
TE Code = AB4
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 091022 | SANDOZ |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB4 | 206641 | ZYDUS PHARMS |
| TIAZAC | DILTIAZEM HYDROCHLORIDE | 420MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB4 | 020401 | BAUSCH |