Details for New Drug Application (NDA): 022497
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NDA 022497 describes FORFIVO XL, which is a drug marketed by Twi Pharms and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FORFIVO XL profile page.
The generic ingredient in FORFIVO XL is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
The generic ingredient in FORFIVO XL is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 022497
| Tradename: | FORFIVO XL |
| Applicant: | Twi Pharms |
| Ingredient: | bupropion hydrochloride |
| Patents: | 1 |
Pharmacology for NDA: 022497
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 022497
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORFIVO XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497 | NDA | TWi Pharmaceuticals, Inc. | 24979-247 | 24979-247-06 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-247-06) |
| FORFIVO XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497 | NDA AUTHORIZED GENERIC | TWi Pharmaceuticals, Inc. | 24979-248 | 24979-248-06 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-248-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
| Approval Date: | Nov 10, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 7,674,479 | Patent Expiration: | Jun 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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