Composition
- Active ingredients
- HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LotionANDA080473-004 · Discontinued
- HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LotionThis page
- HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CreamANDA080472-003 · Discontinued
- HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CreamANDA080472-004 · Discontinued
- HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OintmentANDA080474-004 · Discontinued
- HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OintmentANDA080474-003 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA080473.
At a glance
- Brand name
- Hytone
- Active substance
- hydrocortisone
- Route
- Topical
- Dosage form
- Lotion
- Applicant
- Valeant Intl
- Status
- Discontinued
- FDA approval
- 25 Sept 1972
- Application
- ANDA080473-003