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 : 15909
Submission : 2001-12-21
Status : Active
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 : 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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21014
Submission : 2007-11-02
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 : 21601
Submission : 2008-05-06
Status : Inactive
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Sheffield™ Anhydrous Direct Tableting
Application : Fillers, Diluents & Binders
Excipient Details : Direct Compression
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Anhydrous Lactose
Brand Name : Sheffield™ Anhydrous DT High Velocity
Application : Fillers, Diluents & Binders
Excipient Details : Direct Compression
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Anhydrous Lactose
Brand Name : Sheffield™ Anhydrous 60M
Application : Fillers, Diluents & Binders
Excipient Details : Direct Compression & Granulations
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Anhydrous Lactose
Brand Name : Sheffield™ Anhydrous Impalpable
Application : Fillers, Diluents & Binders
Excipient Details : Direct Compression & Granulations
Pharmacopoeia Ref : USP/NF, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Anhydrous Lactose
Brand Name : Anhydrous Inhalation 120MS
Application : Fillers, Diluents & Binders
Excipient Details : Dry Powder Inhalation
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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