SUPPLIERS
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14052
Submission : 1999-03-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15483
Submission : 2001-06-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24839
Submission : 2011-04-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30290
Submission : 2016-02-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15027
Submission : 2000-09-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27536
Submission : 2013-09-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33935
Submission : 2020-08-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22948
Submission : 2009-07-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21597
Submission : 2008-05-07
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21600
Submission : 2008-05-07
Status : Inactive
Type : IV
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22948
Submission : 2009-07-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27536
Submission : 2013-09-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15027
Submission : 2000-09-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25349
Submission : 2011-10-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21600
Submission : 2008-05-07
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21597
Submission : 2008-05-07
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14052
Submission : 1999-03-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30290
Submission : 2016-02-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24839
Submission : 2011-04-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15483
Submission : 2001-06-12
Status : Active
Type : IV
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NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]LISTED SUPPLIERS
FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : CANTIL
Dosage Form : SOLUTION; ORAL
Application Number : 10679
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : CANTIL
Dosage Form : TABLET; ORAL
Application Number : 10679
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : PRIMAQUINE
Dosage Form : TABLET; ORAL
Application Number : 8316
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : AVAPRO
Dosage Form : TABLET; ORAL
Application Number : 20757
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : AMARYL
Dosage Form : TABLET; ORAL
Application Number : 20496
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : AMBIEN
Dosage Form : TABLET; ORAL
Application Number : 19908
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : CLOMID
Dosage Form : TABLET; ORAL
Application Number : 16131
Country : US
Patented : No
Drug : DEPAKOTE ER
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 21168
Country : US
Patented : No
Drug : TRIDIONE
Dosage Form : TABLET; ORAL
Application Number : 5856
Country : US
Patented : No
Drug : TRIDIONE
Dosage Form : CAPSULE; ORAL
Application Number : 5856
Country : US
Patented : No
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Dossiers
LACTOSE, UNSPECIFIED FORM
Route : BUCCAL
CAS :
UNII : J2B2A4N98G
Potency Amount : 183.3
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : BUCCAL/SUBLINGUAL
CAS :
UNII : J2B2A4N98G
Potency Amount : 296.7
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : IM - IV
CAS :
UNII : J2B2A4N98G
Potency Amount : 20.35
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : IM - IV
CAS :
UNII : J2B2A4N98G
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : IM - IV - SC
CAS :
UNII : J2B2A4N98G
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : IM - IV - SC
CAS :
UNII : J2B2A4N98G
Potency Amount : 13.3
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : INHALATION
CAS :
UNII : J2B2A4N98G
Potency Amount : 20
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : INHALATION
CAS :
UNII : J2B2A4N98G
Potency Amount : 25
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : INHALATION
CAS :
UNII : J2B2A4N98G
Potency Amount : 9
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LACTOSE, UNSPECIFIED FORM
Route : INTRACAVITARY
CAS :
UNII : J2B2A4N98G
Potency Amount : 19.38
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Co Processed Excipients
Brand Name : Disintequik™ MCC 25
Application : Co-Processed Excipients
Excipient Details : Direct Tabletting Operations Where Fast Disintegration Is Required
Application : Co-Processed Excipients
Excipient Details : Orally Disintegrating Tablets
Application : Co-Processed Excipients
Excipient Details : It is a Co-Processed Lactose starch for filler/binder having strong disintegrant properties.
Granulation
Application : Granulation
Excipient Details : Ready-to-use direct compression solution for tablets.
Application : Granulation
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Lactose
Direct Compression
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for lozenges, chewables and effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP/NF and J.P
Technical Specs : Not Available
Ingredient(s) : Lactose
Controlled Modified Release
Application : Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Lactose
Fillers Diluents Binders
Application : Fillers, Diluents & Binders
Excipient Details : It is a Co-Processed Lactose starch for filler/binder having strong disintegrant properties.
Coating Systems Additives
MARKET PLACE
APIs
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27 Jan 2018
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EXCIPIENTS
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31 May 2023
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16 Feb 2023
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13 Jan 2022
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04 May 2021
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12 Feb 2021
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11 May 2020
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