Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075423
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 | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75423ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/20/2012 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-15 | REMS-Proposal |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/15/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/20/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |