24 HR levomilnacipran 80 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Levomilnacipran is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Limitation of Use : Levomilnacipran extended-release capsules are not approved for the management of fibromyalgia. The efficacy and safety of levomilnacipran extended-release capsules for the management of fibromyalgia have not been established. Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults (1) . Limitation of Use : Levomilnacipran extended-release capsules are not approved for the management of fibromyalgia. The efficacy and safety of levomilnacipran extended-release capsules for the management of fibromyalgia have not been established (1) .
Amneal Pharmaceuticals LLC
CAPSULE PINK AN 437
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16 HOW SUPPLIED/STORAGE AND HANDLING
LEVOMILNACIPRAN extended-release capsules are supplied in the following configurations:
LEVOMILNACIPRAN Extended-release capsules, 20 mg are supplied as size β4β capsules, imprinted with βANβ on yellow cap and β411β on white body of the capsules with black ink, filled with white to off-white pellets. They are available as follows: Bottles of 30: NDC 65162-411-03
LEVOMILNACIPRAN Extended-release capsules, 40 mg are supplied as size β3β capsules, imprinted with βANβ on yellow cap and β414β on yellow body of the capsules with black ink, filled with white to off-white pellets. They are available as follows: Bottles of 30: NDC 65162-960-03
LEVOMILNACIPRAN Extended-release capsules, 80 mg are supplied as size β2β capsules, imprinted with βANβ on pink cap and β437β on white body of the capsules with black ink, filled with white to off-white pellets. They are available as follows: Bottles of 30: NDC 65162-437-03
LEVOMILNACIPRAN Extended-release capsules, 120 mg are supplied as size β1β capsules, imprinted with βANβ on pink cap and β455β on pink body of the capsules with black ink, filled with white to off-white pellets. They are available as follows: Bottles of 30: NDC 65162-455-03 Storage and Handling All package configurations: Store at 20Β° to 25Β°C (68Β° to 77Β°F); excursions permitted between 15Β° to 30Β°C (59Β° to 86Β°F) [see USP Controlled Room Temperature] .
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