Details for New Drug Application (NDA): 021947
✉ Email this page to a colleague
NDA 021947 describes FENTORA, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENTORA profile page.
The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 021947
| Tradename: | FENTORA |
| Applicant: | Cephalon |
| Ingredient: | fentanyl citrate |
| Patents: | 2 |
Suppliers and Packaging for NDA: 021947
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | NDA AUTHORIZED GENERIC | Mayne Pharma | 51862-636 | 51862-636-28 | 28 BLISTER PACK in 1 CARTON (51862-636-28) / 1 TABLET in 1 BLISTER PACK (51862-636-01) |
| FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | NDA AUTHORIZED GENERIC | Mayne Pharma | 51862-637 | 51862-637-28 | 28 BLISTER PACK in 1 CARTON (51862-637-28) / 1 TABLET in 1 BLISTER PACK (51862-637-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;BUCCAL, SUBLINGUAL | Strength | EQ 0.1MG BASE | ||||
| Approval Date: | Sep 25, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;BUCCAL, SUBLINGUAL | Strength | EQ 0.2MG BASE | ||||
| Approval Date: | Sep 25, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021947
Complete Access Available with Subscription
