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Generated: April 24, 2017

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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin propanediol profile page.

Summary for NDA: 202293


Pharmacology for NDA: 202293

Suppliers and Packaging for NDA: 202293

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dapagliflozin propanediol
TABLET;ORAL 202293 NDA E.R. Squibb & Sons, L.L.C. 0003-1427 0003-1427-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1427-11)
dapagliflozin propanediol
TABLET;ORAL 202293 NDA E.R. Squibb & Sons, L.L.C. 0003-1427 0003-1427-12 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-1427-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jan 8, 2014TE:RLD:Yes
Patent:7,851,502Patent Expiration:Aug 19, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:7,919,598Patent Expiration:Dec 16, 2029Product Flag?Substance Flag?YDelist Request?
Patent:8,221,786Patent Expiration:Mar 21, 2028Product Flag?YSubstance Flag?Delist Request?

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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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