Amlodipine besylate (USAN) | 210045 | TABLET;ORAL | EQ 5MG BASE;200MG

Amlodipine besylate [USAN]

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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BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for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

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USFDA APPLICATION NUMBER - 210045 / DOSAGE - TABLET;ORAL - EQ 5MG BASE;200MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10mg \| 5mg \| 2.5mg
CELECOXIB(UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)	CELECOXIB	200mg \| 200mg \| 200mg

Inactive Ingredients

Ingredient Name	Burke Therapeutics, LLC
CROSCARMELLOSE SODIUM(M28OL1HH48)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)

Setid 322f926c 99ac 49f8 9cc5 584594f2891f Applno 210045 Form Tablet Oral Dosage Eq 5mg Base 200mg - Drug Product Composition: Amlodipine besylate (USAN)