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Setid A1b077e6 B070 43f2 A98e 380cc635419d Applno 22056 Form For Suspension Delayed Release Oral Dosage Eq 2 5mg Base Packet - Drug Product Composition: Omeprazole Magnesium

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$ API Ref.Price (USD/KG) : 217Xls

USFDA APPLICATION NUMBER - 22056 / DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM(UNII: 426QFE7XLK)
(OMEPRAZOLE - UNII:KG60484QX9)
OMEPRAZOLE10mg | 2.5mg | 40mg | 20mg | 10mg

Inactive Ingredients

Ingredient Name
AstraZeneca Pharmaceuticals LP
ALCOHOL(3K9958V90M)
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS DEXTROSE(5SL0G7R0OK)
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYL ALCOHOL(8PJ61P6TS3)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 7(ECW0LZ41X8)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHACRYLIC ACID(1CS02G8656)
POLYSORBATE 80(6OZP39ZG8H)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
XANTHAN GUM(TTV12P4NEE)