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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-one patents protecting this drug. Additional details are available on the AUVI-Q profile page.

The generic ingredient in AUVI-Q is epinephrine. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

Summary for NDA: 201739

Tradename:
AUVI-Q
Applicant:
Kaleo Inc
Ingredient:
epinephrine
Patents:21
Therapeutic Class:Respiratory Tract Agents
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
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 201739 NDA sanofi-aventis U.S. LLC 0024-5831 0024-5831-00 1 INJECTION in 1 CARTON (0024-5831-00)
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 201739 NDA sanofi-aventis U.S. LLC 0024-5831 0024-5831-02 2 INJECTION in 1 CARTON (0024-5831-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.3MG/DELIVERY
Approval Date:Aug 10, 2012TE:BXRLD:No
Patent:7,731,686Patent Expiration:Jun 1, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,731,690Patent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,749,194Patent Expiration:Oct 30, 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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