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Details for New Drug Application (NDA): 201280

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NDA 201280 describes TRADJENTA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRADJENTA profile page.

The generic ingredient in TRADJENTA is linagliptin. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

Summary for NDA: 201280

Tradename:
TRADJENTA
Applicant:
Boehringer Ingelheim
Ingredient:
linagliptin
Patents:12
Formulation / Manufacturing:see details

Pharmacology for NDA: 201280

Suppliers and Packaging for NDA: 201280

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRADJENTA
linagliptin
TABLET;ORAL 201280 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0140 0597-0140-30 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
TRADJENTA
linagliptin
TABLET;ORAL 201280 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0140 0597-0140-61 100 BLISTER PACK in 1 CARTON (0597-0140-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 2, 2011TE:RLD:Yes
Patent:7,407,955Patent Expiration:May 2, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:8,883,805Patent Expiration:Nov 26, 2025Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Aug 13, 2015
Regulatory Exclusivity Use:LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36


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