Details for New Drug Application (NDA): 215040
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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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 500MG BASE/PACKET | ||||
Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 2.5GM BASE/PACKET | ||||
Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes |
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