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Generated: July 27, 2017

DrugPatentWatch Database Preview

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 nine 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:
1
Applicant:
1
Ingredient:
1
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:Yes
Patent:► SubscribePatent 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:► SubscribePatent Expiration:Mar 2, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Covington
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Cantor Fitzgerald
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US Army
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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