Codisal

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

247 API Suppliers, 81 USDMF, 20 CEP/COS, 17 JDMF, 9 EU WC, 109 KDMF, 108 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

183 Drugs in Development

183 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3504 FDF Dossiers, 737 FDA Orange Book, 1238 Europe, 306 Canada, 105 Australia, 424 South Africa, 694 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 1 Evonik, 13 Rochem International Inc, 32 SPI Pharma, 2 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 14 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 CD Formulation, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

114 Fillers, Diluents & Binders, 73 Thickeners and Stabilizers, 71 Solubilizers, 62 Coating Systems & Additives, 58 Taste Masking, 55 Direct Compression, 54 Parenteral, 53 Topical, 50 Disintegrants & Superdisintegrants, 45 Granulation, 39 Lubricants & Glidants, 38 Film Formers & Plasticizers, 35 Controlled & Modified Release, 28 Chewable & Orodispersible Aids, 27 Emulsifying Agents, 18 Co-Processed Excipients, 17 Surfactant & Foaming Agents, 12 API Stability Enhancers, 10 Rheology Modifiers, 9 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 374 News #PharmaBuzz

GLOBAL SALES INFORMATION

94 US Medicaid Prescriptions, 66 Regulatory FDF Prices, 21 Annual Reports

MARKET PLACE

196 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

42 US Patents, 2 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 36 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

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USFDA APPLICATION NUMBER - 21123 / DOSAGE - TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
acetaminophen(UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	325mg
tramadol hydrochloride(UNII: 9N7R477WCK) (tramadol - UNII:39J1LGJ30J)	tramadol hydrochloride	37.5mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions LLC	Janssen Pharmaceuticals, Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.
CARNAUBA WAX(R12CBM0EIZ)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
magnesium stearate(70097M6I30)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
polysorbate 80(6OZP39ZG8H)
powdered cellulose(SMD1X3XO9M)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
starch, corn(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Setid 717fab70 632e 4a2b A6ce 82e0ced1deaf Applno 21123 Form Tablet Oral Dosage 325mg 37 5mg - Drug Product Composition: Codisal

Codisal

Codisal

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

247 API Suppliers

81 USDMF

20 CEP/COS

17 JDMF

9 EU WC

109 KDMF

108 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

183 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3504 FDF Dossiers

737 FDA Orange Book

1238 Europe

306 Canada

105 Australia

424 South Africa

694 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

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

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

1 Evonik

13 Rochem International Inc

32 SPI Pharma

2 Pharm-RX Chemical

14 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

14 Kirsch Pharma

1 Panvo Organics

4 ACG Worldwide

19 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 CD Formulation

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

4 Finar

17 Gangwal Chemicals

2 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

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

TABLET;ORAL - 325MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons