Details for New Drug Application (NDA): 080473
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NDA 080473 describes HYTONE, which is a drug marketed by Valeant Intl and Dermik Labs and is included in three NDAs. Additional details are available on the HYTONE profile page.
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.
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 080473
| Tradename: | HYTONE |
| Applicant: | Valeant Intl |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080473
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Dosage: | LOTION;TOPICAL | Strength | 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1982 | TE: | RLD: | Yes | |||||
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