1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-

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29 Drugs in Development

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

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ANALYTICAL

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USFDA APPLICATION NUMBER - 22497 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 450MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)	BUPROPION HYDROCHLORIDE	450mg

Inactive Ingredients

Ingredient Name	Edgemont Pharmaceuticals, LLC	Alvogen Inc.
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)
COPOVIDONE K25-31(D9C330MD8B)
HYDROCHLORIC ACID(QTT17582CB)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE OXIDE 2000000(5K3991GVWI)
POLYVINYL ACETATE(32K497ZK2U)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: 1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-