Amoxicillin Trihydrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

77 API Suppliers, 44 USDMF, 30 CEP/COS, 6 JDMF, 3 EU WC, 41 KDMF, 22 NDC API, 4 VMF, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1413 FDF Dossiers, 209 FDA Orange Book, 570 Europe, 113 Canada, 67 Australia, 153 South Africa, 301 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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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- 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE, TABLET, EXTENDED RELEASE;ORAL -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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 5 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 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, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 24 Controlled & Modified Release, 23 Fillers, Diluents & Binders, 20 Thickeners and Stabilizers, 15 Direct Compression, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 9 Granulation, 9 Topical, 8 Co-Processed Excipients, 7 Film Formers & Plasticizers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Chewable & Orodispersible Aids, 2 Parenteral

DIGITAL CONTENT

9 DATA COMPILATION #PharmaFlow, 75 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 545 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

101 APIs, 44 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

REF. STANDARDS & IMPURITIES

3 EDQM, 6 USP, 22 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

$ Xls

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USFDA APPLICATION NUMBER - 50813 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	775mg

Inactive Ingredients

Ingredient Name	Shionogi Inc.	Fera Pharmaceuticals, LLC	Pragma Pharmaceuticals, LLC	Vernalis Therapeutics, Inc.
ALUMINUM OXIDE(LMI26O6933)
cellulose, microcrystalline(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
crospovidone(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
hypromellose acetate succinate 16070722 (3 mm2/s)(24P2YXD2PW)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
magnesium stearate(70097M6I30)
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol 400(B697894SGQ)
polyoxyl 35 castor oil(6D4M1DAL6O)
povidone(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
shellac(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Amoxicillin Trihydrate