Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065102
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | 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 |
---|---|---|---|---|---|---|---|
09/17/2002 | 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 |
---|---|---|---|---|---|
10/28/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
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03/28/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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11/24/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/05/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/14/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/25/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |