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 : 20568
Submission : 2007-05-10
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 : 28498
Submission : 2014-05-23
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 : 38990
Submission : 2023-10-16
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
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 PRESCRIPTION COMPOUNDING
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 : 24141
Submission : 2010-09-14
Status : Inactive
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 : 38990
Submission : 2023-10-16
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
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Sheffield™ Spray Dried 316 Fast Flo®
Application : Direct Compression
Excipient Details : Pharmaceutical excipient used in direct compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Spray Dried 315
Application : Direct Compression
Excipient Details : Pharmaceutical excipient used in direct compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Direct Compression
Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 80.m
Application : Direct Compression
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 : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
MARKET PLACE
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REF. STANDARDS & IMPURITIES