Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078654
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 08/27/2014 | 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 |
|---|---|---|---|---|---|
| 05/01/2023 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/17/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |