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. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
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 |
| Formulation / Manufacturing: | see details |
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. | 17270-553 | 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: | OTC | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.125MG/INH | ||||
| Approval Date: | Nov 7, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 26, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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