Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062247
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHLORAMPHENICOL | CHLORAMPHENICOL | 250MG | 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 |
---|---|---|---|---|---|---|---|
04/28/1980 | 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 |
---|---|---|---|---|---|
05/30/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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09/02/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/16/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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08/14/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |