Details for New Drug Application (NDA): 215875
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NDA 215875 describes ADRENALIN, which is a drug marketed by Endo Operations and is included in three NDAs. It is available from eight suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADRENALIN profile page.
The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 215875
| Tradename: | ADRENALIN |
| Applicant: | Endo Operations |
| Ingredient: | epinephrine |
| Patents: | 4 |
Pharmacology for NDA: 215875
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 215875
Suppliers and Packaging for NDA: 215875
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875 | NDA | Endo USA, Inc. | 42023-315 | 42023-315-10 | 10 BAG in 1 CARTON (42023-315-10) / 250 mL in 1 BAG (42023-315-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2MG/250ML (8MCG/ML) | ||||
| Approval Date: | Apr 21, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,653,646 | Patent Expiration: | Mar 21, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,083,698 | Patent Expiration: | Mar 21, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK | ||||||||
| Patent: | 11,207,280 | Patent Expiration: | Mar 21, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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