Details for New Drug Application (NDA): 207534
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NDA 207534 describes SYMJEPI, which is a drug marketed by Adamis Pharms Corp and is included in one NDA. There is one patent protecting this drug. Additional details are available on the SYMJEPI profile page.
The generic ingredient in SYMJEPI is epinephrine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
The generic ingredient in SYMJEPI is epinephrine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 207534
| Tradename: | SYMJEPI |
| Applicant: | Adamis Pharms Corp |
| Ingredient: | epinephrine |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 207534
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.3MG/0.3ML (0.3MG/0.3ML) | ||||
| Approval Date: | Jun 15, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 20, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 0.15MG/0.3ML (0.15MG/0.3ML) | ||||
| Approval Date: | Sep 27, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 20, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF EPINEPHRINE | ||||||||
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