Details for New Drug Application (NDA): 021338
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NDA 021338 describes IONSYS, which is a drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this drug. Additional details are available on the IONSYS profile page.
The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the fentanyl hydrochloride profile page.
The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the fentanyl hydrochloride profile page.
Summary for 021338
| Tradename: | IONSYS |
| Applicant: | The Medicines Co |
| Ingredient: | fentanyl hydrochloride |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYSTEM;IONTOPHORESIS, TRANSDERMAL | Strength | EQ 40MCG BASE/ACTIVATION | ||||
| Approval Date: | May 22, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 1, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 30, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 21, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE | ||||||||
Expired US Patents for NDA 021338
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