HYDROMORPHONE HCL

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 11 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 17 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

211 FDF Dossiers, 76 FDA Orange Book, 31 Europe, 42 Canada, 37 Australia, 5 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Evonik, 2 Rochem International Inc, 15 SPI Pharma, 6 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 2 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 37 Direct Compression, 31 Parenteral, 31 Thickeners and Stabilizers, 30 Controlled & Modified Release, 29 Granulation, 28 Solubilizers, 27 Film Formers & Plasticizers, 20 Disintegrants & Superdisintegrants, 20 Taste Masking, 20 Topical, 18 Lubricants & Glidants, 16 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 35 Regulatory FDF Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 5 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 19892 / DOSAGE - TABLET;ORAL - 8MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydromorphone hydrochloride(UNII: L960UP2KRW) (hydromorphone - UNII:Q812464R06)	hydromorphone hydrochloride	2mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Bryant Ranch Prepack	Cardinal Health	Elite Laboratories, Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	McKesson Corporation	Mckesson Rxpak Inc	PD-Rx Pharmaceuticals, Inc.	Precision Dose Inc.	Purdue Pharma LP	TAGI Pharma, Inc.	V1 Pharma Llc	Avera McKennan Hospital
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C RED NO. 30(2S42T2808B)
D&C YELLOW NO. 10(35SW5USQ3G)
glycerin(PDC6A3C0OX)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
methylparaben(A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
propylparaben(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM METABISULFITE(4VON5FNS3C)
STEARIC ACID(4ELV7Z65AP)
sucrose(C151H8M554)
water(059QF0KO0R)

Setid 39003b2e Be25 402e B755 96c7b41a7639 Applno 19892 Form Tablet Oral Dosage 8mg - Drug Product Composition: HYDROMORPHONE HCL