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 nine 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. Thirty-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. Thirty-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: | 9 |
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: | 11,590,286 | Patent Expiration: | Dec 12, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,947,017 | Patent Expiration: | Mar 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,021,344 | Patent Expiration: | Nov 2, 2029 | 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 | 201739-002 | Aug 10, 2012 | 9,737,669 | ⤷ Get Started Free |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | 7,918,823 | ⤷ Get Started Free |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | 7,731,690 | ⤷ Get Started Free |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-003 | Nov 17, 2017 | 8,361,029 | ⤷ Get Started Free |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | 8,016,788 | ⤷ Get Started Free |
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | 7,918,823 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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