Composition
- Active ingredients
- CEFTIBUTEN DIHYDRATE EQ 400MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CEFTIBUTEN DIHYDRATE EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · For suspensionNDA050686-001 · Discontinued
- CEFTIBUTEN DIHYDRATE EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · For suspensionNDA050686-002 · Discontinued
- CEFTIBUTEN DIHYDRATE EQ 400MG BASE · CapsuleThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA050685.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Cedax
- Active substance
- ceftibuten dihydrate
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Burke Therap
- Status
- Discontinued
- FDA approval
- 20 Dec 1995
- Application
- NDA050685-002