Oxycodone HCl

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 18 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

808 FDF Dossiers, 290 FDA Orange Book, 345 Europe, 49 Canada, 52 Australia, 17 South Africa, 55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG, SOLUTION;ORAL - 100MG/5ML, SOLUTION;ORAL - 5MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 18MG, CAPSULE, EXTENDED RELEASE;ORAL - 27MG, CAPSULE, EXTENDED RELEASE;ORAL - 36MG, CAPSULE, EXTENDED RELEASE;ORAL - 9MG, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 80MG, TABLET;ORAL - 325MG;5MG

RELATED EXCIPIENT COMPANIES

4 Evonik, 7 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 1 Clariant, 22 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 40 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 55 Controlled & Modified Release, 51 Direct Compression, 43 Thickeners and Stabilizers, 42 Disintegrants & Superdisintegrants, 39 Taste Masking, 36 Granulation, 33 Solubilizers, 30 Film Formers & Plasticizers, 28 Parenteral, 26 Lubricants & Glidants, 24 Co-Processed Excipients, 22 Topical, 22 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 API Stability Enhancers, 9 Emulsifying Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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4 US Medicaid Prescriptions, 273 Finished Drug Prices, 18 Annual Reports

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PATENTS & EXCLUSIVITIES

225 US Patents, 4 US Exclusivities, 54 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 7 Others

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USFDA APPLICATION NUMBER - 208090 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYCODONE(UNII: CD35PMG570) (OXYCODONE - UNII:CD35PMG570)	OXYCODONE	13.5mg

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC
CARNAUBA WAX(R12CBM0EIZ)
FERRIC OXIDE RED(1K09F3G675)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MYRISTIC ACID(0I3V7S25AW)
PEG-32 STEARATE(33GX5WQC0M)
SILICON DIOXIDE(ETJ7Z6XBU4)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)
YELLOW WAX(2ZA36H0S2V)

Drug Product Composition: Oxycodone HCl

Oxycodone HCl

Oxycodone HCl

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

13 USDMF

11 CEP/COS

1 JDMF

1 EU WC

7 KDMF

18 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

808 FDF Dossiers

290 FDA Orange Book

345 Europe

49 Canada

52 Australia

17 South Africa

55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG

SOLUTION;ORAL - 100MG/5ML

SOLUTION;ORAL - 5MG/5ML

SOLUTION;ORAL - 5MG/5ML

TABLET;ORAL - 5MG

TABLET;ORAL - 7.5MG

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG

CAPSULE, EXTENDED RELEASE;ORAL - 18MG

CAPSULE, EXTENDED RELEASE;ORAL - 27MG

CAPSULE, EXTENDED RELEASE;ORAL - 36MG

CAPSULE, EXTENDED RELEASE;ORAL - 9MG

TABLET, EXTENDED RELEASE;ORAL - 10MG

TABLET, EXTENDED RELEASE;ORAL - 15MG

TABLET, EXTENDED RELEASE;ORAL - 20MG

TABLET, EXTENDED RELEASE;ORAL - 30MG

TABLET, EXTENDED RELEASE;ORAL - 40MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 80MG

TABLET;ORAL - 325MG;5MG

RELATED EXCIPIENT COMPANIES

4 Evonik

7 Rochem International Inc

22 SPI Pharma

2 Seqens

18 DKSH

2 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

16 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

3 Pfanstiehl

4 ACG Worldwide

14 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

38 BASF

1 Bioplus Life Sciences

1 Clariant

22 Corel Pharma Chem

7 DFE Pharma

2 Finar

13 Gangwal Chemicals

12 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons