Drugs@FDA: FDA-Approved Drugs
Company: FACTA FARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
03/27/1978 | 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 |
---|---|---|---|---|---|
05/01/2000 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/01/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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09/19/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
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03/01/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
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06/23/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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07/12/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
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10/01/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
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10/25/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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02/07/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
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02/28/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |