Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073475
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/30/1993 | 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 |
|---|---|---|---|---|---|
| 04/29/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2011 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/15/2010 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2005 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/03/2005 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 07/24/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/05/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/22/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 12/16/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |