Details for New Drug Application (NDA): 214697
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NDA 214697 describes NEFFY, which is a drug marketed by Ars Pharms Operation and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NEFFY profile page.
The generic ingredient in NEFFY 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 NEFFY 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 214697
| Tradename: | NEFFY |
| Applicant: | Ars Pharms Operation |
| Ingredient: | epinephrine |
| Patents: | 7 |
Pharmacology for NDA: 214697
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 214697
Suppliers and Packaging for NDA: 214697
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEFFY | epinephrine | SPRAY;NASAL | 214697 | NDA | ARS Pharmaceuticals Operations, Inc. | 82580-020 | 82580-020-02 | 2 BLISTER PACK in 1 CARTON (82580-020-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / 100 uL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 2MG/SPRAY | ||||
| Approval Date: | Aug 9, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 6, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 6, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 6, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS | ||||||||
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