GDUFA
DMF Review : N/A
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DMF Number : 35341
Submission : 2020-12-24
Status : Active
Type : IV
Certificate Number : R0-CEP 2023-020 - Rev 00
Issue Date : 2023-08-28
Type : Chemical
Substance Number : 892
Status : Valid
GDUFA
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DMF Number : 2855
Submission : 1977-02-08
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-076 - Rev 01
Issue Date : 2015-06-26
Type : Chemical
Substance Number : 892
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 2297
Submission : 1974-06-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 34076
Submission : 2019-09-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 29013
Submission : 2015-01-22
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-344 - Rev 00
Issue Date : 2021-02-05
Type : Chemical
Substance Number : 892
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 26093
Submission : 2012-04-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 26094
Submission : 2012-04-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 28408
Submission : 2014-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-195 - Rev 01
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 892
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 28972
Submission : 2014-12-29
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-337 - Rev 00
Issue Date : 2020-11-13
Type : Chemical
Substance Number : 892
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29000
Submission : 2015-01-08
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : ARAVA
Dosage Form : TABLET; ORAL
Application Number : 20905
Country : US
Patented : No
Drug : TRICOR
Dosage Form : TABLET; ORAL
Application Number : 21656
Country : US
Patented : No
Drug : NEXICLON XR
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 22500
Country : US
Patented : Yes
Drug : ESOMEPRAZOLE MAGNESIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 211571
Country : US
Patented : No
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Drug : AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form : TABLET; ORAL
Application Number : 203874
Country : US
Patented : No
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug : AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Dosage Form : CAPSULE; ORAL
Application Number : 77183
Country : US
Patented : No
Drug : LEVOFLOXACIN
Dosage Form : TABLET; ORAL
Application Number : 76710
Country : US
Patented : No
Drug : TRIGLIDE
Dosage Form : TABLET; ORAL
Application Number : 21350
Country : US
Patented : No
Drug : DEFERIPRONE
Dosage Form : TABLET; ORAL
Application Number : 208800
Country : US
Patented : No
Drug : LAMOTRIGINE
Dosage Form : TABLET; ORAL
Application Number : 78525
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Application : Direct Compression
Excipient Details : Crospovidone is an insoluble polymer of N-vinyl-2-pyrrolidone that is used as a disintegrant in pharmaceutical tablets.
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Pharmacopoeia Ref : Ph.Eur., USP/NF and JP
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Application : Direct Compression
Excipient Details : Maximum disintegration
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Application : Direct Compression
Excipient Details : Roller compaction & direct compression including slight disintegration functionality, Reduces sedimentation in suspensions. Solubilizer in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Application : Direct Compression
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Granule / Pellet, Orodispersible Tablet, Tablet
Grade : Not Available
Category : Direct Compression
Application : Direct Compression
Excipient Details : Kollidon CL-F has a balance of strong disintegration and optimal surface homogeneity.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Dosage Form : Granule / Pellet, Orodispersible Tablet, Tablet
Grade : Not Available
Category : Direct Compression
Application : Direct Compression
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Application : Granulation
Excipient Details : Crospovidone is used as a granulating agent in pharmaceutical formulations such as tablets, granules, and pellets.
Application : Granulation
Excipient Details : Tablets, Granules, Pills, Disintegrants and fillers.
Application : Granulation
Excipient Details : Ready-to-use direct compression solution for tablets.
Pharmacopoeia Ref : Ph.Eur., USP/NF and JP
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Application : Granulation
Excipient Details : Roller compaction & direct compression including slight disintegration functionality, Reduces sedimentation in suspensions. Solubilizer in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Application : Granulation
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Granule / Pellet, Orodispersible Tablet, Tablet
Grade : Not Available
Category : Granulation
Application : Granulation
Pharmacopoeia Ref : Ph. Eur., USP, JP: Crospovidon...
Technical Specs : Not Available
Ingredient(s) : Polyvinylpyrrolidone Crosslinked
Application : Co-Processed Excipients
Excipient Details : Orally Disintegrating Tablets
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30 Sep 2021
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