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FDA NDA · NDA205920

PRIMATENE MIST

epinephrine inhalation

Sponsor: ARMSTRONG PHARMS

APPLICATION
NDA205920
TYPE
NDA
ORIGINAL APPROVAL
2018-11-07
LATEST ACTION
2018-11-07
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Over-the-counter

Products

PRIMATENE MIST · ReferenceOver-the-counter
EPINEPHRINE 0.125MG/INH · AEROSOL, METERED · INHALATION

Approval history

2018-11-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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