Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076409
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2003 | 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 |
|---|---|---|---|---|---|
| 06/22/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/13/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/15/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/20/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |