Details for New Drug Application (NDA): 204168
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NDA 204168 describes FETZIMA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FETZIMA profile page.
The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 204168
| Tradename: | FETZIMA |
| Applicant: | Abbvie |
| Ingredient: | levomilnacipran hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 204168
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 204168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168 | NDA | Allergan, Inc. | 0456-2200 | 0456-2200-07 | 1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00) |
| FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168 | NDA | Allergan, Inc. | 0456-2202 | 0456-2202-28 | 1 KIT in 1 BLISTER PACK (0456-2202-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 25, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM STUDY LVM-MD-11 AND LVM-MD-14 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 2, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 23, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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