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Last Updated: July 14, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205920

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NDA 205920 describes PRIMATENE MIST, which is a drug marketed by Armstrong Pharms and Wyeth Cons and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the PRIMATENE MIST profile page.

The generic ingredient in PRIMATENE MIST is epinephrine. There are twenty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 205920
Applicant:Armstrong Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMATENE MIST epinephrine AEROSOL, METERED;INHALATION 205920 NDA Armstrong Pharmaceuticals, Inc. 17270-553 17270-553-00 1 INHALER in 1 CARTON (17270-553-00) > 160 AEROSOL in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, METERED;INHALATIONStrength0.125MG/INH
Approval Date:Nov 7, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 7, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jan 26, 2026Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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