Composition
- Active ingredients
- CEFDINIR 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CEFDINIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleNDA050739-001 · Discontinued
- CEFDINIR 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · For suspensionThis page
- CEFDINIR 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · For suspensionNDA050749-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA050749.
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
- Omnicef
- Active substance
- cefdinir
- Route
- Oral
- Dosage form
- For suspension
- Applicant
- Abbvie
- Status
- Discontinued
- FDA approval
- 4 Dec 1997
- Application
- NDA050749-001