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Details for New Drug Application (NDA): 206073

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NDA 206073 describes GLYXAMBI, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the GLYXAMBI profile page.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

Summary for NDA: 206073

Tradename:
GLYXAMBI
Applicant:
Boehringer Ingelheim
Ingredient:
empagliflozin; linagliptin
Patents:14
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 0597-0164-07 1 BOTTLE in 1 CARTON (0597-0164-07) > 7 TABLET, FILM COATED in 1 BOTTLE
GLYXAMBI
empagliflozin; linagliptin
TABLET;ORAL 206073 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164 0597-0164-10 1000 TABLET, FILM COATED in 1 BOTTLE (0597-0164-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;5MG
Approval Date:Jan 30, 2015TE:RLD:No
Patent:7,407,955Patent Expiration:May 2, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:7,579,449Patent Expiration:Nov 5, 2025Product Flag?Substance Flag?YDelist Request?
Patent:7,713,938Patent Expiration:Apr 15, 2027Product Flag?YSubstance Flag?YDelist 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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