GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23260
Submission : 2009-11-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23260
Submission : 2009-11-12
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : GENGRAF
Dosage Form : CAPSULE; ORAL
Application Number : 65003
Country : US
Patented : No
Drug : NORVIR
Dosage Form : CAPSULE; ORAL
Application Number : 20945
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : SOLUTION; ORAL
Application Number : 65054
Country : US
Patented : No
Drug : CYCLOSPORINE
Dosage Form : CAPSULE; ORAL
Application Number : 65044
Country : US
Patented : No
Drug : PARICALCITOL
Dosage Form : CAPSULE; ORAL
Application Number : 91412
Country : US
Patented : No
Drug : PACLITAXEL
Dosage Form : INJECTABLE; INJECTION
Application Number : 90130
Country : US
Patented : No
Drug : PACLITAXEL
Dosage Form : INJECTABLE; INJECTION
Application Number : 91540
Country : US
Patented : No
Drug : PACLITAXEL
Dosage Form : INJECTABLE; INJECTION
Application Number : 207326
Country : US
Patented : No
Drug : MEGESTROL ACETATE
Dosage Form : SUSPENSION; ORAL
Application Number : 75997
Country : US
Patented : No
Drug : VITAMIN K1
Dosage Form : INJECTABLE; INJECTION
Application Number : 87955
Country : US
Patented : No
POLYOXYL 35 CASTOR OIL
Route : INTRAVENOUS
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 52.7
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : INTRAVESICAL
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 50
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : IV(INFUSION)
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 65
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : IV(INFUSION)
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 52.75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : OPHTHALMIC
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : OPHTHALMIC
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : ORAL
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 120
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : ORAL
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 599.4
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : ORAL
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 515
Potency Unit : MG/1ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLYOXYL 35 CASTOR OIL
Route : ORAL
CAS : 61791126
UNII : 6D4M1DAL6O
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Dosage Form : Injectable / Parenteral, Solution, Tablet
Grade : Parenteral, Oral, Topical
Category : Solubilizers
Brand Name : Polyoxyethylene (35) Castor Oil
Application : Solubilizers
Excipient Details : It is used as solubilizers for paclitaxel, cyclosporine, vitamin K1.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Castor Oil
Dosage Form : Emulsion, Injectable / Parenteral, Solution, Suspension
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Hydrogenated Castor Oil
Dosage Form : Capsule, Emulsion, Gel, Solution, Transdermal patches
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Nonionic emulsifier for O-W emulsions, Solubilizer
Pharmacopoeia Ref : Ph. Eur. Macrogolglycerol Rici...
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Castor Oil
Dosage Form : Injectable / Parenteral, Solution
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents
Application : Emulsifying Agents
Excipient Details : Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Hydrogenated Castor Oil
Dosage Form : Emulsion, Injectable / Parenteral, Solution
Grade : Not Available
Category : Parenteral
Application : Parenteral
Excipient Details : Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Hydrogenated Castor Oil
Brand Name : Polyoxyethylene (35) Castor Oil
Application : API Stability Enhancers
Excipient Details : It is used as solubilizers for paclitaxel, cyclosporine, vitamin K1.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Castor Oil
Application : API Stability Enhancers
Excipient Details : For sensitive active ingredients to improve their stability
Pharmacopoeia Ref : Ph. Eur.: Macrogolglycerol Ric...
Technical Specs : Not Available
Ingredient(s) : Polyoxyl 35 Castor Oil
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Category : Surfactant & Foaming Agents
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