Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065081
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/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 |
---|---|---|---|---|---|---|---|
07/27/2001 | 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 |
---|---|---|---|---|---|
07/02/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |