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Serving 500+ biopharmaceutical companies globally:

Dow
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Federal Trade Commission
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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202293

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NDA 202293 describes FARXIGA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the FARXIGA profile page.

The generic ingredient in FARXIGA is dapagliflozin propanediol. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin propanediol profile page.

Summary for NDA: 202293

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:11

Pharmacology for NDA: 202293

Suppliers and Packaging for NDA: 202293

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FARXIGA
dapagliflozin propanediol
TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 0310-6205-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)
FARXIGA
dapagliflozin propanediol
TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 0310-6205-95 1 BLISTER PACK in 1 CARTON (0310-6205-95) > 7 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jan 8, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 11, 2018
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLITFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA
Regulatory Exclusivity Expiration:Jan 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Oct 4, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS


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Serving 500+ biopharmaceutical companies globally:

Novartis
Deloitte
Boehringer Ingelheim
Mallinckrodt
Cantor Fitzgerald
US Army
Dow
McKinsey
US Department of Justice
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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