Details for New Drug Application (NDA): 077449
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NDA 077449 describes FENTANYL-87, which is a drug marketed by Difgen Pharms, Mylan Technologies, and Zydus Pharms, and is included in three NDAs. It is available from five suppliers. Additional details are available on the FENTANYL-87 profile page.
The generic ingredient in FENTANYL-87 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.
The generic ingredient in FENTANYL-87 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 077449
| Tradename: | FENTANYL-87 |
| Applicant: | Difgen Pharms |
| Ingredient: | fentanyl |
| Patents: | 0 |
Pharmacology for NDA: 077449
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 077449
Suppliers and Packaging for NDA: 077449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | INGENUS PHARMACEUTICALS, LLC | 50742-549 | 50742-549-05 | 5 POUCH in 1 CARTON (50742-549-05) / 1 PATCH in 1 POUCH (50742-549-01) / 72 h in 1 PATCH |
| FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | INGENUS PHARMACEUTICALS, LLC | 50742-550 | 50742-550-05 | 5 POUCH in 1 CARTON (50742-550-05) / 1 PATCH in 1 POUCH (50742-550-01) / 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: | Oct 20, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 50MCG/HR | ||||
| Approval Date: | Oct 20, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 75MCG/HR | ||||
| Approval Date: | Oct 20, 2008 | TE: | AB | RLD: | No | ||||
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