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Setid 7b48ddec E815 45f4 9ca0 5c0daaf56f30 Applno 8372 Form Injectable Injection Dosage 80 Units Ml - Drug Product Composition: Adrenocorticotropic Hormone

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USFDA APPLICATION NUMBER - 8372 / DOSAGE - INJECTABLE;INJECTION - 80 UNITS/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORTICOTROPIN(UNII: K0U68Q2TXA)
(CORTICOTROPIN - UNII:K0U68Q2TXA)
CORTICOTROPIN80[USP' in 1 | 40[USP' in 0.5 | 80[USP' in 1

Inactive Ingredients

Ingredient Name
Mallinckrodt ARD LLC
ACETIC ACID(Q40Q9N063P)
CYSTEINE(K848JZ4886)
GELATIN, UNSPECIFIED(2G86QN327L)
PHENOL(339NCG44TV)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)