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FDA Approval Activities for this Drug
CEFTIBUTEN DIHYDRATE Capsule; 400MG BASE CEDAX BIOVAIL |
050686 CEFTIBUTEN DIHYDRATE For Suspension; 180MG BASE/5ML CEDAX BIOVAIL |
050686 CEFTIBUTEN DIHYDRATE For Suspension; 90MG BASE/5ML CEDAX BIOVAIL | CEDAX (ceftibuten) Capsules, Shionogi USA, Inc., Labeling Revision | CEDAX (ceftibuten) Oral Suspension, Shionogi USA, Inc., Labeling Revision | Cedax (ceftibuten dihydrate) Capsules, Pernix Therapeutics, LLC, Labeling Revision | Cedax (ceftibuten dihydrate) Oral Suspension, Pernix Therapeutics, LLC, Labeling Revision | Cedax (ceftibuten dihydrate) Oral Suspension, Pernix Therapeutics, LLS, Manufacturing Change or Addition
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