Details for New Drug Application (NDA): 204200
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NDA 204200 describes ADRENALIN, which is a drug marketed by Par Sterile Products and is included in three NDAs. It is available from eight suppliers. There are six 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-one 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-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 204200
| Tradename: | ADRENALIN |
| Applicant: | Par Sterile Products |
| Ingredient: | epinephrine |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
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 | 24357-012 | 24357-012-12 | 1 KIT in 1 CARTON (24357-012-12) * 1 mL in 1 PACKET (68599-5804-1) * 1 mL in 1 VIAL (42023-159-01) |
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: | ⤷ Try a Trial | Patent Expiration: | Mar 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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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