Composition
- Active ingredients
- AMIKACIN SULFATE EQ 50MG BASE/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AMIKACIN SULFATE EQ 250MG BASE/ML · InjectableANDA062562-002 · Discontinued
- AMIKACIN SULFATE EQ 50MG BASE/ML · InjectableANDA062562-001 · Discontinued
- AMIKACIN SULFATE EQ 250MG BASE/ML · InjectableANDA062311-002 · Discontinued
- AMIKACIN SULFATE EQ 50MG BASE/ML · InjectableThis page
- AMIKACIN SULFATE EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA050495-001 · Discontinued
- AMIKACIN SULFATE EQ 250MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA050495-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA062311.
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
- Amikin
- Active substance
- amikacin sulfate
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Apothecon
- Status
- Discontinued
- FDA approval
- 22 Jan 1981
- Application
- ANDA062311-001