GDUFA
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DMF Number : 32957
Submission : 2018-07-18
Status : Active
Type : IV
GDUFA
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DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV

GDUFA
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DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV

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DMF Number : 38990
Submission : 2023-10-16
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DMF Number : 37267
Submission : 2022-09-15
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DMF Number : 37688
Submission : 2022-11-12
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DMF Number : 21598
Submission : 2008-05-07
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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

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GDUFA
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DMF Number : 32957
Submission : 2018-07-18
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Type : IV
GDUFA
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DMF Number : 37267
Submission : 2022-09-15
Status : Active
Type : IV

GDUFA
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DMF Number : 37688
Submission : 2022-11-12
Status : Active
Type : IV

GDUFA
DMF Review : N/A
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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
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Pay. Date :
DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV

GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Sheffield™ Monohydrate 313
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
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
Excipients Web Link
Brand Name : Sheffield™ Monohydrate 310
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate 312
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Granulation
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 : 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
MARKET PLACE
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REF. STANDARDS & IMPURITIES
CAS Number : 64044-51-5
Quantity Per Vial : 500
Sale Unit : mg
Price : $290.00
Details : Material Origin- Animal-Cow; USMCA- No; KORUS...
Monograph :
Storage :
Code/Batch No : Catalog #1356701 / R084R0

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