GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24780
Submission : 2011-03-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38440
Submission : 2023-05-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24780
Submission : 2011-03-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38440
Submission : 2023-05-30
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : MARQIBO KIT
Dosage Form : INJECTABLE, LIPOSOMAL; INTRAVENOUS
Application Number : 202497
Country : US
Patented : No
Drug : DOXIL (LIPOSOMAL)
Dosage Form : INJECTABLE, LIPOSOMAL; INJECTION
Application Number : 50718
Country : US
Patented : No
Drug : HYDROCORTISONE
Dosage Form : LOTION; TOPICAL
Application Number : 40417
Country : US
Patented : No
Drug : ONIVYDE
Dosage Form : INJECTABLE, LIPOSOMAL; INTRAVENOUS
Application Number : 207793
Country : US
Patented : Yes
Drug : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING; ORAL
Application Number : 200221
Country : US
Patented : No
Drug : DEPOCYT
Dosage Form : INJECTABLE, LIPOSOMAL; INJECTION
Application Number : 21041
Country : US
Patented : No
Drug : HYDROCORTISONE
Dosage Form : CREAM; TOPICAL
Application Number : 40879
Country : US
Patented : No
Drug : DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Dosage Form : INJECTABLE, LIPOSOMAL; INJECTION
Application Number : 203263
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Dosage Form : Injectable / Parenteral
Grade : Topical, Parenteral
Category : Co-Processed Excipients
Application : Co-Processed Excipients
Excipient Details : Presome ACD-1 is a mixture of HSPC/Cholesterol/MPEG2000-DSPE(3:1:1) that can greatly reduce the complexity of liposome production. It is used in parenteral dosage forms.
Pharmacopoeia Ref : NA
Technical Specs : Phospholipid/Cholesterol/MPEG2000-DSPE(3:1:1) Mixture
Ingredient(s) : Cholesterol Excipient
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
Category : Surfactant & Foaming Agents
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical, Parenteral
Category : Emulsifying Agents
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