Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075401
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/10/2003 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75401TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075401.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2011 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |