GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28713
Submission : 2014-10-03
Status : Active
Type : IV

Certificate Number : R1-CEP 2001-082 - Rev 02
Issue Date : 2015-07-10
Type : TSE
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2001-012 - Rev 01
Issue Date : 2008-05-16
Type : TSE
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2008-014 - Rev 01
Issue Date : 2016-08-31
Type : Chemical
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2000-279 - Rev 00
Issue Date : 2006-04-02
Type : TSE
Substance Number :
Status : Valid

Certificate Number : CEP 2024-019 - Rev 00
Issue Date : 2025-09-10
Type : Chemical
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2001-403 - Rev 01
Issue Date : 2009-08-28
Type : TSE
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2012-378 - Rev 00
Issue Date : 2018-08-17
Type : Chemical
Substance Number : 1671
Status : Valid

Certificate Number : R1-CEP 2000-373 - Rev 00
Issue Date : 2006-07-12
Type : TSE
Substance Number : 496
Status : Valid

Certificate Number : R1-CEP 2001-338 - Rev 01
Issue Date : 2009-08-31
Type : TSE
Substance Number : 496
Status : Valid

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28713
Submission : 2014-10-03
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Certificate Number : R1-CEP 2000-373 - Rev 00
Status : Valid
Issue Date : 2006-07-12
Type : TSE
Substance Number : 496

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Glycerol, (EMERY® 905 Glycerine, EMERY® 912 Gl...
Certificate Number : R1-CEP 2001-338 - Rev 01
Status : Valid
Issue Date : 2009-08-31
Type : TSE
Substance Number : 496

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Glycerol, EMERY® 916 Glycerine
Certificate Number : R1-CEP 2001-403 - Rev 01
Status : Valid
Issue Date : 2009-08-28
Type : TSE
Substance Number : 496

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Certificate Number : R1-CEP 1999-012 - Rev 03
Status : Valid
Issue Date : 2011-01-07
Type : Chemical
Substance Number : 496

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Certificate Number : R0-CEP 2007-177 - Rev 00
Status : Expired
Issue Date : 2008-02-19
Type : Chemical
Substance Number : 496

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Glycerol, Product Code: 1132200
Certificate Number : R1-CEP 2001-074 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2013-04-23
Type : TSE
Substance Number : 496

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Certificate Number : R1-CEP 2001-012 - Rev 01
Status : Valid
Issue Date : 2008-05-16
Type : TSE
Substance Number : 496

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Certificate Number : R1-CEP 2000-279 - Rev 00
Status : Valid
Issue Date : 2006-04-02
Type : TSE
Substance Number :

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Certificate Number : R0-CEP 2012-371 - Rev 00
Status : Expired
Issue Date : 2015-02-24
Type : Chemical
Substance Number : 496

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Certificate Number : R0-CEP 2001-080 - Rev 01
Status : Expired
Issue Date : 2005-03-18
Type : TSE
Substance Number : 496

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 : Glycerol Multi-Compendial
Application : Parenteral
Excipient Details : A & C's Glycerol multi-compendial is an excipient that meets USP-NF, EP and BP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Glycerol Excipient
Excipients Web Link
Application : Parenteral
Excipient Details : A & C's Glycerol is an excipient which meets the USP monograph.
Excipients Web Link
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Oral, Topical, Parenteral
Category : Topical
Dosage Form : Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers
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