Details for New Drug Application (NDA): 021947
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NDA 021947 describes FENTORA, which is a drug marketed by Cephalon and is included in one NDA. It is available from two suppliers. There are four 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. Ten 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. Ten 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: | 4 |
Pharmacology for NDA: 021947
| Mechanism of Action | Full Opioid Agonists |
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 | 51862-635 | 51862-635-28 | 28 BLISTER PACK in 1 CARTON (51862-635-28) / 1 TABLET in 1 BLISTER PACK (51862-635-01) |
| 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) |
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: | ⤷ Subscribe | Patent Expiration: | Jun 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 30, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021947
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-006 | Mar 2, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-004 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-004 | Sep 25, 2006 | ⤷ Subscribe | ⤷ Subscribe |
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