Details for New Drug Application (NDA): 204168
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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 | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 2, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 23, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) |
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