Frovatriptan (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 69238-1539-9

Frovatriptan Succinate Tablets, 2.5 mg

Rx Only

Carton of 9 Tablets

Amneal Pharmaceuticals LLC

1
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1
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FROVATRIPTAN
frovatriptan succinate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1539
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FROVATRIPTAN SUCCINATE (FROVATRIPTAN) FROVATRIPTAN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1539-9 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 9 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (69238-1539-9)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211292 11/13/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 915076126 label (69238-1539), pack (69238-1539)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 650762060 manufacture (69238-1539)

Revised: 09/2019 Amneal Pharmaceuticals NY LLC

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