Hydrocodone Bitartrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 17 USDMF, 1 KDMF, 18 NDC API, 11 Listed Suppliers

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

344 FDF Dossiers, 337 FDA Orange Book, 3 Canada, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, SOLUTION;ORAL - 4MG/5ML;5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG;5MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 11 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 15 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Bioplus Life Sciences, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

99 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 48 Direct Compression, 43 Controlled & Modified Release, 41 Disintegrants & Superdisintegrants, 40 Thickeners and Stabilizers, 34 Granulation, 31 Film Formers & Plasticizers, 30 Solubilizers, 28 Taste Masking, 22 Parenteral, 21 Lubricants & Glidants, 21 Topical, 20 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 97 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Annual Reports

MARKET PLACE

3 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

254 US Patents

254 US Patents

REF. STANDARDS & IMPURITIES

3 USP, 7 Others

Xls

Filters

Xls

USFDA APPLICATION NUMBER - 204307 / DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4mg in 5
HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)	HYDROCODONE BITARTRATE	5mg in 5

Inactive Ingredients

Ingredient Name	Acella Pharmaceuticals, LLC	Hawthorn Pharmaceuticals, Inc.	Tris Pharma Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
GLYCERIN(PDC6A3C0OX)
GRAPE(6X543N684K)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM CITRATE(1Q73Q2JULR)
SUCROSE(C151H8M554)
WATER(059QF0KO0R)

Drug Product Composition: Hydrocodone Bitartrate