GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14644
Submission : 1999-12-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21599
Submission : 2008-05-06
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21601
Submission : 2008-05-06
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15916
Submission : 2002-03-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16066
Submission : 2002-07-10
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16284
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16285
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18730
Submission : 2005-09-06
Status : Active
Type : IV
NDC Package Code : 51552-0618
Start Marketing Date : 1998-04-01
End Marketing Date : 2026-06-01
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
FINISHED DOSAGE FORMULATIONS
ANHYDROUS LACTOSE
Route : BUCCAL
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 23.75
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : IM - IV
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : IM - IV
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : INTRACAVITARY
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 4.75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : INTRAVENOUS
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 28.75
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : IV(INFUSION)
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 46.06
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 71.91
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 40
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ANHYDROUS LACTOSE
Route : ORAL
CAS : 63423
UNII : 3SY5LH9PMK
Potency Amount : 117
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Direct Compression
Pharmacopoeia Ref : Conforms to Ph. Eur., Lactose ...
Technical Specs : Density- Tapped density- 906 g/l, Bulk density- 722 g/l; Particle...
Ingredient(s) : Anhydrous Lactose
Brand Name : Microlex® LCA 60.m
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCA 120.m, Microlex® LCA 20...
Ingredient(s) : Anhydrous Lactose
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17 May 2018
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