Details for New Drug Application (NDA): 205029
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NDA 205029 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Bpi Labs, Intl Medication Sys, Hospira, and Teva Pharms Usa, and is included in eight NDAs. It is available from nine suppliers. There are three patents protecting this drug. Additional details are available on the EPINEPHRINE profile page.
The generic ingredient in EPINEPHRINE 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 EPINEPHRINE 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 205029
| Tradename: | EPINEPHRINE |
| Applicant: | Bpi Labs |
| Ingredient: | epinephrine |
| Patents: | 3 |
Pharmacology for NDA: 205029
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 205029
Suppliers and Packaging for NDA: 205029
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 205029 | NDA | Henry Schein, Inc. | 0404-9857 | 0404-9857-01 | 1 AMPULE in 1 BAG (0404-9857-01) / 1 mL in 1 AMPULE |
| EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 205029 | NDA | A-S Medication Solutions | 50090-3039 | 50090-3039-0 | 25 AMPULE in 1 BOX (50090-3039-0) / 1 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | Strength | 1MG/ML (1MG/ML) | ||||
| Approval Date: | Jul 29, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patented Use: | EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patented Use: | INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 15, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patented Use: | EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS | ||||||||
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