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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215040

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LEGUBETI (ACETYLCYSTEINE LYSINE)
EQ 500MG BASE/PACKET
Marketing Status: Discontinued
Active Ingredient: ACETYLCYSTEINE LYSINE
Proprietary Name: LEGUBETI
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 500MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215040
Product Number: 001
Approval Date: Feb 13, 2024
Applicant Holder Full Name: GALEPHAR PHARMACEUTICAL RESEARCH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LEGUBETI (ACETYLCYSTEINE LYSINE)
EQ 2.5GM BASE/PACKET
Marketing Status: Discontinued
Active Ingredient: ACETYLCYSTEINE LYSINE
Proprietary Name: LEGUBETI
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 2.5GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215040
Product Number: 002
Approval Date: Feb 13, 2024
Applicant Holder Full Name: GALEPHAR PHARMACEUTICAL RESEARCH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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