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Setid 350eb39e 6072 4467 8f57 Ed6edcdbccd8 Applno 20768 Form Tablet Oral Dosage 5mg - Drug Product Composition: Zolmitriptan

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$ API Ref.Price (USD/KG) : 9,352Xls

USFDA APPLICATION NUMBER - 20768 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ZOLMITRIPTAN(UNII: 2FS66TH3YW)
(ZOLMITRIPTAN - UNII:2FS66TH3YW)
ZOLMITRIPTAN5mg | 2.5mg | 5mg | 2.5mg

Inactive Ingredients

Ingredient Name
Impax Generics
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS LACTOSE(3SY5LH9PMK)
ASPARTAME(Z0H242BBR1)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
ORANGE(5EVU04N5QU)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)