Details for New Drug Application (NDA): 019813
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The generic ingredient in DURAGESIC-75 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 019813
Tradename: | DURAGESIC-75 |
Applicant: | Janssen Pharms |
Ingredient: | fentanyl |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019813
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 7, 1990 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 7, 1990 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 7, 1990 | TE: | RLD: | Yes |
Expired US Patents for NDA 019813
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | DURAGESIC-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DURAGESIC-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-004 | Aug 7, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DURAGESIC-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-004 | Aug 7, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | DURAGESIC-50 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-003 | Aug 7, 1990 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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