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Setid A0bcb8ab 089d 449f 9bd6 7857d64e1692 Applno 88763 Form Syrup Oral Dosage 10mg 5ml 6 25mg 5ml - Drug Product Composition: Codeine Phosphate

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$ API Ref.Price (USD/KG) : 377Xls

USFDA APPLICATION NUMBER - 88763 / DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
CODEINE PHOSPHATE10mg in 5
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494)
PROMETHAZINE HYDROCHLORIDE6.25mg in 5

Inactive Ingredients

Ingredient Name
Actavis Mid Atlantic LLC
Bryant Ranch Prepack
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CORN SYRUP(9G5L16BK6N)
D&C RED NO. 33(9DBA0SBB0L)
FD&C BLUE NO. 1(H3R47K3TBD)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
WATER(059QF0KO0R)