Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064156
Company: RANBAXY
Company: RANBAXY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/28/1997 | 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 |
---|---|---|---|---|---|
01/31/2001 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/23/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/29/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/30/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
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04/26/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |