(+)-Benzphetamine hydrochloride | 12427 | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

BENZPHETAMINE HYDROCHLORIDE

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 8 USDMF, 1 EU WC, 4 NDC API, 4 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 13 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 34 Direct Compression, 31 Controlled & Modified Release, 22 Disintegrants & Superdisintegrants, 22 Solubilizers, 21 Thickeners and Stabilizers, 19 Lubricants & Glidants, 19 Granulation, 18 Film Formers & Plasticizers, 18 Co-Processed Excipients, 14 Parenteral, 12 Topical, 11 Taste Masking, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

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USFDA APPLICATION NUMBER - 12427 / DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzphetamine hydrochloride(UNII: 43DWT87QT7) (benzphetamine - UNII:0M3S43XK27)	benzphetamine hydrochloride	50mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions LLC	PD-Rx Pharmaceuticals, Inc.
calcium stearate(776XM7047L)
FD&C Red No. 3(PN2ZH5LOQY)
FD&C Yellow No. 6(H77VEI93A8)
lactose(J2B2A4N98G)
povidone(FZ989GH94E)
sorbitol(506T60A25R)
starch, corn(O8232NY3SJ)

Drug Product Composition: (+)-Benzphetamine hydrochloride