Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215422

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LYVISPAH (BACLOFEN)
5MG/PACKET
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LYVISPAH
Dosage Form; Route of Administration: GRANULES; ORAL
Strength: 5MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215422
Product Number: 001
Approval Date: Nov 22, 2021
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LYVISPAH (BACLOFEN)
10MG/PACKET
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LYVISPAH
Dosage Form; Route of Administration: GRANULES; ORAL
Strength: 10MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215422
Product Number: 002
Approval Date: Nov 22, 2021
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LYVISPAH (BACLOFEN)
20MG/PACKET
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LYVISPAH
Dosage Form; Route of Administration: GRANULES; ORAL
Strength: 20MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215422
Product Number: 003
Approval Date: Nov 22, 2021
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information