Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | 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 |
---|---|---|---|---|---|---|---|
04/29/1993 | 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 |
---|---|---|---|---|---|
06/30/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2015 | 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. |
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08/30/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
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08/30/2005 | SUPPL-27 | Labeling |
Label is not available on this site. |
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07/29/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/06/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/20/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/21/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
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05/16/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/16/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/05/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/24/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/25/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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02/18/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/22/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/15/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/16/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/23/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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12/22/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/12/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |