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
FINISHED DOSAGE FORMULATIONS
Drug : ARAVA
Dosage Form : TABLET; ORAL
Application Number : 20905
Country : US
Patented : No
Drug : PLAVIX
Dosage Form : TABLET; ORAL
Application Number : 20839
Country : US
Patented : No
HYDROCHLOROTHIAZIDE; IRBESARTAN
Drug : AVALIDE
Dosage Form : TABLET; ORAL
Application Number : 20758
Country : US
Patented : No
Drug : AMBIEN CR
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 21774
Country : US
Patented : No
Drug : BIAXIN
Dosage Form : FOR SUSPENSION; ORAL
Application Number : 50698
Country : US
Patented : No
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Drug : TARKA
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20591
Country : US
Patented : No
Drug : BIAXIN
Dosage Form : TABLET; ORAL
Application Number : 50662
Country : US
Patented : No
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug : VIEKIRA PAK (COPACKAGED)
Dosage Form : TABLET; ORAL
Application Number : 206619
Country : US
Patented : Yes
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
Brand Name : Microlose™ M60 P60
Application : Fillers, Diluents & Binders
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 716 g/l, Bulk density- 599 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : Lactose is widely used as a filler and diluent in tablets and capsules, and to a more limited extent in lyophilized products and infant formulas.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate Inhalation 120 M
Application : Fillers, Diluents & Binders
Excipient Details : Dry Powder Inhalation
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield Monohydrate Inhalation 80 M
Application : Fillers, Diluents & Binders
Excipient Details : Dry Powder Inhalation
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Granulation
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Application : Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 80.m
Application : Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCM 180.m, Microlex® LCM 20...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 120.s
Application : Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlose™ M60 P60
Application : Co-Processed Excipients
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Application : Co-Processed Excipients
Excipient Details : Direct Compression
Pharmacopoeia Ref : NF/EP/JP
Technical Specs : Not Available
Ingredient(s) : Spray Dried Monohydrate Lactose
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
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