Details for New Drug Application (NDA): 215040
✉ Email this page to a colleague
NDA 215040 describes LEGUBETI, which is a drug marketed by Galephar and is included in one NDA. Additional details are available on the LEGUBETI profile page.
The generic ingredient in LEGUBETI is acetylcysteine lysine. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine lysine profile page.
The generic ingredient in LEGUBETI is acetylcysteine lysine. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine lysine profile page.
Summary for 215040
| Tradename: | LEGUBETI |
| Applicant: | Galephar |
| Ingredient: | acetylcysteine lysine |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215040
Generic Entry Date for 215040*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
FOR SOLUTION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 500MG BASE/PACKET | ||||
| Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 2.5GM BASE/PACKET | ||||
| Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Complete Access Available with Subscription
