Details for New Drug Application (NDA): 019821
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NDA 019821 describes SORIATANE, which is a drug marketed by Stiefel Labs Inc and is included in one NDA. Additional details are available on the SORIATANE profile page.
The generic ingredient in SORIATANE is acitretin. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acitretin profile page.
The generic ingredient in SORIATANE is acitretin. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acitretin profile page.
Summary for 019821
| Tradename: | SORIATANE |
| Applicant: | Stiefel Labs Inc |
| Ingredient: | acitretin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019821
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 28, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 28, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 17.5MG | ||||
| Approval Date: | Aug 6, 2009 | TE: | RLD: | Yes | |||||
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