USFDA APPLICATION NUMBER - 22272 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 40mg |
Inactive Ingredients
Ingredient Name | Actavis Pharma, Inc. | Lake Erie Medical DBA Quality Care Products LLC | Par Pharmaceutical, Inc. | Ranbaxy Pharmaceuticals Inc. | Rebel Distributors Corp | Bryant Ranch Prepack | PD-Rx Pharmaceuticals, Inc. | STAT Rx USA LLC |
---|---|---|---|---|---|---|---|---|
ALUMINUM OXIDE(LMI26O6933) | ||||||||
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2) | ||||||||
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | ||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||
ferric oxide red(1K09F3G675) | ||||||||
ferric oxide yellow(EX438O2MRT) | ||||||||
ferrosoferric oxide(XM0M87F357) | ||||||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||||
hydroxypropyl cellulose(RFW2ET671P) | ||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||
HYPROMELLOSES(3NXW29V3WO) | ||||||||
lactose(J2B2A4N98G) | ||||||||
magnesium stearate(70097M6I30) | ||||||||
polyethylene glycol 400(B697894SGQ) | ||||||||
POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||||
POLYSORBATE 80(6OZP39ZG8H) | ||||||||
povidone(FZ989GH94E) | ||||||||
sodium hydroxide(55X04QC32I) | ||||||||
sorbic acid(X045WJ989B) | ||||||||
stearyl alcohol(2KR89I4H1Y) | ||||||||
talc(7SEV7J4R1U) | ||||||||
titanium dioxide(15FIX9V2JP) | ||||||||
triacetin(XHX3C3X673) |
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