Details for New Drug Application (NDA): 021875
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NDA 021875 describes NUVIGIL, which is a drug marketed by Nuvo Pharms and is included in one NDA. It is available from nine suppliers. 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
Summary for 021875
| Tradename: | NUVIGIL |
| Applicant: | Nuvo Pharms |
| Ingredient: | armodafinil |
| Patents: | 0 |
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 | ||||
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DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jun 15, 2007 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021875
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | 7,132,570*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | Jun 15, 2007 | 4,927,855*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-005 | Mar 26, 2009 | 7,132,570*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-002 | Mar 26, 2009 | 4,927,855*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-003 | Jun 15, 2007 | 4,927,855*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | 4,927,855*PED | ⤷ Get Started Free |
| Nuvo Pharms | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | Jun 15, 2007 | 7,297,346*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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