Details for New Drug Application (NDA): 205920
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The generic ingredient in PRIMATENE MIST is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 205920
Tradename: | PRIMATENE MIST |
Applicant: | Armstrong Pharms |
Ingredient: | epinephrine |
Patents: | 1 |
Pharmacology for NDA: 205920
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 205920
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. | 17270-5530 | 17270-5530-0 | 1 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.125MG/INH | ||||
Approval Date: | Nov 7, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 26, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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