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Details for New Drug Application (NDA): 204168

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NDA 204168 describes FETZIMA, which is a drug marketed by Forest Labs Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the FETZIMA profile page.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are five 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 NDA: 204168

Tradename:
FETZIMA
Applicant:
Forest Labs Inc
Ingredient:
levomilnacipran hydrochloride
Patents:3

Pharmacology for NDA: 204168

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 USA, Inc. 0456-2202 0456-2202-28 1 KIT in 1 BLISTER PACK (0456-2202-28)
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 204168 NDA Allergan USA, Inc. 0456-2212 0456-2212-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jul 25, 2013TE:RLD:No
Patent:8,865,937Patent Expiration:May 23, 2032Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jul 25, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
Patent:8,481,598Patent Expiration:Mar 2, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)


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