Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076395
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTZAC | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTZAC | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTZAC | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTZAC | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTZAC | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/24/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/09/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |