Composition
- Active ingredients
- NYSTATIN 100,000 UNITS/GM; TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*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.
- NYSTATIN 100,000 UNITS/GM; TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · CreamANDA062606-001 · Discontinued
- NYSTATIN 100,000 UNITS/GM; TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OintmentANDA060572-001 · Discontinued
- NYSTATIN 100,000 UNITS/GM; TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · CreamThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA060576.
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
- Mycolog-II
- Active substance
- nystatin
- Route
- Topical
- Dosage form
- Cream
- Applicant
- Delcor Asset Corp
- Status
- Discontinued
- FDA approval
- 1 May 1985
- Application
- ANDA060576-002