Details for New Drug Application (NDA): 080472
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The generic ingredient in HYTONE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 080472
Tradename: | HYTONE |
Applicant: | Valeant Intl |
Ingredient: | hydrocortisone |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080472
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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