Details for New Drug Application (NDA): 201739
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NDA 201739 describes AUVI-Q, which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting this drug. Additional details are available on the AUVI-Q profile page.
The generic ingredient in AUVI-Q 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 AUVI-Q 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 201739
| Tradename: | AUVI-Q |
| Applicant: | Kaleo Inc |
| Ingredient: | epinephrine |
| Patents: | 18 |
Pharmacology for NDA: 201739
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 201739
Suppliers and Packaging for NDA: 201739
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1320 | 51662-1320-1 | .3 mL in 1 DOSE PACK (51662-1320-1) |
| AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1320 | 51662-1320-2 | 2 DOSE PACK in 1 CARTON (51662-1320-2) / .3 mL in 1 DOSE PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | EQ 0.3MG/DELIVERY | ||||
| Approval Date: | Aug 10, 2012 | TE: | BX | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 30, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 201739
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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