GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32957
Submission : 2018-07-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37688
Submission : 2022-11-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38990
Submission : 2023-10-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37267
Submission : 2022-09-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21598
Submission : 2008-05-07
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24141
Submission : 2010-09-14
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32957
Submission : 2018-07-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37267
Submission : 2022-09-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37688
Submission : 2022-11-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21598
Submission : 2008-05-07
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24141
Submission : 2010-09-14
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38990
Submission : 2023-10-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV
NDC Package Code : 51552-0136
Start Marketing Date : 1998-04-01
End Marketing Date : 2026-02-12
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
FINISHED DOSAGE FORMULATIONS
LACTOSE MONOHYDRATE
Route : IM - IV
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : IM - IV
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : INTRAMUSCULAR
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 1.05
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : INTRAVENOUS
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 25
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : INTRAVENOUS
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : IV(INFUSION)
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 20
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : ORAL
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 430.42
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : ORAL
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 141
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : ORAL
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 147.6
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE MONOHYDRATE
Route : ORAL
CAS :
UNII : EWQ57Q8I5X
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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01 Aug 2022
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