levomilnacipran Extended Release Oral Capsule

Brand(s)
Fetzima
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2014-07-21)
Oldest Current Product
2013-07-25
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\LEVOMILNACIPRAN
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\LEVOMILNACIPRAN HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\LEVOMILNACIPRAN HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\LEVOMILNACIPRAN

product(s) by strength(s)

24 hr levomilnacipran 120 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004562212FetzimaNDAForest Laboratories, Inc2013-07-25LEVOMILNACIPRAN HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA204168f371258d-91b3-4b6a-ac99-434a1964c3af

24 hr levomilnacipran 20 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004562220FetzimaNDAForest Laboratories, Inc2013-07-25LEVOMILNACIPRAN HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA204168f371258d-91b3-4b6a-ac99-434a1964c3af

24 hr levomilnacipran 40 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004562240FetzimaNDAForest Laboratories, Inc2013-07-25LEVOMILNACIPRAN HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA204168f371258d-91b3-4b6a-ac99-434a1964c3af

24 hr levomilnacipran 80 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004562280FetzimaNDAForest Laboratories, Inc2013-07-25LEVOMILNACIPRAN HYDROCHLORIDEORALCAPSULE, EXTENDED RELEASENDA204168f371258d-91b3-4b6a-ac99-434a1964c3af

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204168FETZIMAFOREST LABORATORIES INC2013-07-25pRE43879, TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
p8481598, TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
p8865937, SUBSTANCE
NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT). [2018-07-25]NDA204168_001, NDA204168_002, NDA204168_003, NDA204168_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204168_001RXLEVOMILNACIPRAN HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2013-07-25FETZIMA
2NDA204168_002RXLEVOMILNACIPRAN HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2013-07-25FETZIMA
3NDA204168_003RXLEVOMILNACIPRAN HYDROCHLORIDE (EQ 80MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2013-07-25FETZIMA
4NDA204168_004RXLEVOMILNACIPRAN HYDROCHLORIDE (EQ 120MG BASE)ORALCAPSULE, EXTENDED RELEASETrue2013-07-25FETZIMA

patent(s)

#idexpiration dateapplication(s)
1p8481598 (view patent)2031-03-02NDA204168
2p8865937 (view patent)2032-05-23NDA204168
3pRE43879 (view patent)2023-06-03NDA204168

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f371258d-91b3-4b6a-ac99-434a1964c3af (view SPL)These highlights do not include all the information needed to use FETZIMA safely and effectively. See full prescribing information for FETZIMA. FETZIMA (levomilnacipran) extended-release capsules, for oral use Initial U.S. Approval: 2009 (milnacipran)prescriptionHuman PrescriptionForest Laboratories, IncAPI MANUFACTURE, PACK2014-07-215004562212, 004562220, 004562240, 004562280, 004562202

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII