Amoxicillin, (R*)-isomer

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 40 USDMF, 30 CEP/COS, 5 JDMF, 2 EU WC, 37 KDMF, 21 NDC API, 4 VMF, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1499 FDF Dossiers, 208 FDA Orange Book, 570 Europe, 115 Canada, 71 Australia, 146 South Africa, 389 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 22 Fillers, Diluents & Binders, 21 Thickeners and Stabilizers, 19 Controlled & Modified Release, 14 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 10 Topical, 9 Granulation, 9 Direct Compression, 7 Rheology Modifiers, 7 Co-Processed Excipients, 6 Film Formers & Plasticizers, 5 API Stability Enhancers, 5 Taste Masking, 5 Empty Capsules, 5 Solubilizers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids

DIGITAL CONTENT

77 News #PharmaBuzz

77 News #PharmaBuzz

GLOBAL SALES INFORMATION

25 US Medicaid Prescriptions, 545 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

105 APIs, 44 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 6 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 22 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

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USFDA APPLICATION NUMBER - 50725 / DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400mg in 5
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	57mg in 5

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals,Inc.	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	A-S Medication Solutions LLC	Aurobindo Pharma Limited	Hikma Pharmaceutical	Hikma Pharmaceuticals USA Inc.	NorthStar Rx LLC	REMEDYREPACK INC.	Sandoz GmbH	Sandoz Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)
ASPARTAME(Z0H242BBR1)
BANANA(4AJZ4765R9)
CARAMEL(T9D99G2B1R)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CETYL ALCOHOL(936JST6JCN)
CHERRY(BUC5I9595W)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
DEXTROSE(IY9XDZ35W2)
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C RED NO. 40(WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
ORANGE(5EVU04N5QU)
POLYSORBATE 80(6OZP39ZG8H)
RASPBERRY(4N14V5R27W)
SACCHARIN SODIUM(SB8ZUX40TY)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SUCCINIC ACID(AB6MNQ6J6L)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Amoxicillin, (R*)-isomer