Amlodipine besylate (USAN) | 19787 | TABLET;ORAL | EQ 10MG BASE

Amlodipine besylate [USAN]

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

187 API Suppliers, 41 USDMF, 44 CEP/COS, 25 JDMF, 36 EU WC, 89 KDMF, 27 NDC API, 60 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1542 FDF Dossiers, 462 FDA Orange Book, 763 Europe, 130 Canada, 50 South Africa, 137 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 22 SPI Pharma, 22 DKSH, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 5 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 35 BASF, 1 CD Formulation, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 49 Direct Compression, 48 Disintegrants & Superdisintegrants, 47 Thickeners and Stabilizers, 38 Solubilizers, 37 Granulation, 31 Lubricants & Glidants, 29 Controlled & Modified Release, 29 Topical, 25 Parenteral, 23 Chewable & Orodispersible Aids, 23 Film Formers & Plasticizers, 20 Taste Masking, 15 Co-Processed Excipients, 14 Rheology Modifiers, 13 Emulsifying Agents, 10 Surfactant & Foaming Agents, 10 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

43 News #PharmaBuzz

43 News #PharmaBuzz

GLOBAL SALES INFORMATION

49 US Medicaid Prescriptions, 40 Regulatory FDF Prices

MARKET PLACE

40 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

37 US Patents, 195 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 3 USP, 7 JP, 1 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 19787 / DOSAGE - TABLET;ORAL - EQ 10MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Aurobindo Pharma Limited	Avera McKennan Hospital	Bryant Ranch Prepack	Cardinal Health	Clinical Solutions Wholesale	Clinical Solutions Wholesale, LLC	Contract Pharmacy Services-PA	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Exelan Pharmaceuticals, Inc.	KAISER FOUNDATION HOSPITALS	Lake Erie Medical DBA Quality Care Products LLC	Legacy Pharmaceutical Packaging, LLC	Lupin Pharmaceuticals, Inc.	McKesson Contract Packaging	Medsource Pharmaceuticals	Mylan Institutional Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	New Horizon Rx Group, LLC	NuCare Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceutical Inc.	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	QPharma Inc	Quality Care Products, LLC	RedPharm Drug, Inc.	REMEDYREPACK INC.	Rising Pharmaceuticals, Inc.	St Marys Medical Park Pharmacy	Teva Pharmaceuticals USA, Inc.	Torrent Pharmaceuticals Limited	Unichem Pharmaceuticals (USA), Inc.	Unit Dose Services	Vivimed Labs Limited	Wock	State of Florida DOH Central Pharmacy	A-S Medication Solutions	Amneal Pharmaceuticals LLC	DIRECT RX	Macleods Pharmaceuticals Limited	Major Pharmaceuticals	Par Pharmaceutical	Safecor Health, LLC	TYA Pharmaceuticals	Apotex Corp.	AvPAK	DOH CENTRAL PHARMACY	Hikma Pharmaceutical	Hikma Pharmaceuticals USA Inc.	Marlex Pharmaceuticals Inc	Physicians Total Care, Inc.	State of	Aphena Pharma Solutions - Tennessee, LLC	medsource pharmaceuticals	Mylan Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	Upsher-Smith Laboratories, LLC	West-Ward Pharmaceuticals Corp.	Blenheim Pharmacal, Inc.	Cardinal Health 107, LLC	Epic Pharma, LLC	Golden State Medical Supply, Inc.	McKesson Corporation dba SKY Packaging	NCS HealthCare of KY, Inc dba Vangard Lab	Wockhardt USA LLC.	Zydus Pharmaceuticals USA Inc.	Par Phar
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
Mannitol(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (5856J3G2A2)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)

Setid F699d501 3f23 4261 904a 4877ba200c38 Applno 19787 Form Tablet Oral Dosage Eq 10mg Base - Drug Product Composition: Amlodipine besylate (USAN)