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Details for New Drug Application (NDA): 019813

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NDA 019813 describes DURAGESIC-75, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from four suppliers. Additional details are available on the DURAGESIC-75 profile page.

The generic ingredient in DURAGESIC-75 is fentanyl. There are thirty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the fentanyl profile page.

Summary for NDA: 019813

Tradename:
DURAGESIC-100
Applicant:
Janssen Pharms
Ingredient:
fentanyl
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 019813

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 019813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL 019813 NDA Sandoz,Inc. 0781-7240 0781-7240-55 5 POUCH in 1 BOX (0781-7240-55) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL 019813 NDA Sandoz,Inc. 0781-7241 0781-7241-55 5 POUCH in 1 BOX (0781-7241-55) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength100MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:No

Expired Orange Book Patents for NDA: 019813

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 19904,144,317► subscribe
Janssen Pharms
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-001Aug 7, 19904,060,084► subscribe
Janssen Pharms
DURAGESIC-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 19904,144,317► subscribe
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