Details for New Drug Application (NDA): 204200
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The generic ingredient in ADRENALIN 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 204200
Tradename: | ADRENALIN |
Applicant: | Endo Operations |
Ingredient: | epinephrine |
Patents: | 2 |
Pharmacology for NDA: 204200
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 204200
Suppliers and Packaging for NDA: 204200
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200 | NDA | Henry Schein, Inc. | 0404-9810 | 0404-9810-01 | 1 VIAL, SINGLE-USE in 1 BAG (0404-9810-01) / 1 mL in 1 VIAL, SINGLE-USE |
ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200 | NDA | Focus Health Group | 24357-011 | 24357-011-13 | 1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | ||||
Approval Date: | Dec 7, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS |
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