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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062247
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.

09/02/1992 SUPPL-10 Labeling

Label is not available on this site.

11/16/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/14/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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