bsp; Imprint Code 503;2mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64725-0515-1 30 in 1 CONTAINER
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022037 09/02/2009
INTUNIV
guanfacine tablet, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0513(NDC:54092-513)
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE (UNII: PML56A160O) (GUANFACINE - UNII:30OMY4G3MK) GUANFACINE 1 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONES (UNII: FZ989GH94E)
CROSPOVIDONE (UNII: 68401960MK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
FUMARIC ACID (UNII: 88XHZ13131)
PRODUCT CHARACTERISTICS
Color WHITE (white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 503;1mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64725-0513-1 100 in 1 BOTTLE
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022037 09/02/2009
LABELER - TYA PHARMACEUTICALS (938389038)
REGISTRANT - TYA PHARMACEUTICALS (938389038)
ESTABLISHMENT
Name Address ID/FEI Business Operations
TYA Pharmaceuticals 938389038 RELABEL(64725-0515, 64725-0513) , REPACK(64725-0515
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