Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076911
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Discontinued | None | No | No |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/29/2004 | 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 |
|---|---|---|---|---|---|
| 11/30/2010 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/05/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |