Details for New Drug Application (NDA): 077154
✉ Email this page to a colleague
The generic ingredient in FENTANYL-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 077154
Tradename: | FENTANYL-75 |
Applicant: | Specgx Llc |
Ingredient: | fentanyl |
Patents: | 0 |
Pharmacology for NDA: 077154
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 077154
Suppliers and Packaging for NDA: 077154
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077154 | ANDA | SpecGx LLC | 0406-9037 | 0406-9037-76 | 5 POUCH in 1 CARTON (0406-9037-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH |
FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077154 | ANDA | SpecGx LLC | 0406-9062 | 0406-9062-76 | 5 POUCH in 1 CARTON (0406-9062-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 25MCG/HR | ||||
Approval Date: | Feb 9, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 50MCG/HR | ||||
Approval Date: | Feb 9, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 75MCG/HR | ||||
Approval Date: | Feb 9, 2011 | TE: | AB | RLD: | No |
Complete Access Available with Subscription