Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065113
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 | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
11/29/2002 | 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 |
---|---|---|---|---|---|
06/30/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/31/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/04/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/29/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
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04/23/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |