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Generated: November 20, 2018

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Details for New Drug Application (NDA): 201739

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NDA 201739 describes AUVI-Q, which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from two suppliers. There are twenty-four patents protecting this drug. Additional details are available on the AUVI-Q profile page.

The generic ingredient in AUVI-Q is epinephrine. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 201739
Tradename:AUVI-Q
Applicant:Kaleo Inc
Ingredient:epinephrine
Patents:24
Formulation / Manufacturing:see details
Pharmacology for NDA: 201739
Suppliers and Packaging for NDA: 201739
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1320 51662-1320-1 .3 mL in 1 DOSE PACK (51662-1320-1)
AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1321 51662-1321-1 .15 mL in 1 DOSE PACK (51662-1321-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.3MG/DELIVERY
Approval Date:Aug 10, 2012TE:BXRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 1, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 30, 2028Product Flag?YSubstance Flag?Delist Request?

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