Details for New Drug Application (NDA): 022256
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NDA 022256 describes SAVELLA, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SAVELLA profile page.
The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for 022256
| Tradename: | SAVELLA |
| Applicant: | Abbvie |
| Ingredient: | milnacipran hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022256
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 022256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256 | NDA | Allergan, Inc. | 0456-1500 | 0456-1500-55 | 1 BLISTER PACK in 1 CARTON (0456-1500-55) / 1 KIT in 1 BLISTER PACK |
| SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256 | NDA | Allergan, Inc. | 0456-1510 | 0456-1510-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0456-1510-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Jan 14, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 19, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF FIBROMYALGIA | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jan 14, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 19, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF FIBROMYALGIA | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 14, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 19, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF FIBROMYALGIA | ||||||||
Expired US Patents for NDA 022256
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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