GDUFA
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DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-372 - Rev 00
Issue Date : 2021-02-05
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-314 - Rev 01
Issue Date : 2023-05-09
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-196 - Rev 01
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
Certificate Number : CEP 2009-020 - Rev 01
Issue Date : 2024-03-26
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 32698
Submission : 2018-11-22
Status : Active
Type : IV
GDUFA
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DMF Number : 33415
Submission : 2018-12-10
Status : Active
Type : IV
GDUFA
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DMF Number : 33592
Submission : 2019-02-21
Status : Active
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GDUFA
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DMF Number : 22604
Submission : 2009-01-19
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-079 - Rev 01
Issue Date : 2017-02-09
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 32695
Submission : 2018-03-27
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-078 - Rev 01
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Status : Withdrawn by Holder
GDUFA
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DMF Number : 78
Submission : 1966-09-08
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : USP-NF, EP, BP, IP, JP, FCC
Technical Specs : PVP K-K-30/ K-17/ K19/ K25/ K90
Ingredient(s) : Povidone
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
MARKET PLACE
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