Details for New Drug Application (NDA): 021875
✉ Email this page to a colleague
NDA 021875 describes NUVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NUVIGIL profile page.
The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
Summary for 021875
| Tradename: | NUVIGIL |
| Applicant: | Cephalon |
| Ingredient: | armodafinil |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021875
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUVIGIL | armodafinil | TABLET;ORAL | 021875 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3090 | 0093-3090-56 | 30 TABLET in 1 BOTTLE (0093-3090-56) |
| NUVIGIL | armodafinil | TABLET;ORAL | 021875 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3092 | 0093-3092-56 | 30 TABLET in 1 BOTTLE (0093-3092-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 15, 2007 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 18, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 29, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 26, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 18, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Expired US Patents for NDA 021875
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
