Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205920

PRIMATENE MIST (EPINEPHRINE)
0.125MG/INH Marketing Status: Over-the-counter

Active Ingredient: EPINEPHRINE
Proprietary Name: PRIMATENE MIST
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.125MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205920
Product Number: 001
Approval Date: Nov 7, 2018
Applicant Holder Full Name: ARMSTRONG PHARMACEUTICALS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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