Details for New Drug Application (NDA): 018662
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The generic ingredient in ACCUTANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 018662
Tradename: | ACCUTANE |
Applicant: | Hoffmann La Roche |
Ingredient: | isotretinoin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018662
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 7, 1982 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 7, 1982 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Mar 28, 1983 | TE: | RLD: | Yes |
Expired US Patents for NDA 018662
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | 4,464,394*PED | ⤷ Subscribe |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | 4,322,438 | ⤷ Subscribe |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | 4,322,438 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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