Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076990
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/13/2004 | 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 |
|---|---|---|---|---|---|
| 06/07/2021 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2021 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2021 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2021 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2015 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2010 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/17/2010 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/09/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/17/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/17/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/07/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/10/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/09/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |