Product Details for NDA 215422
LYVISPAH (BACLOFEN)
5MG/PACKET
Marketing Status: Prescription
10MG/PACKET
Marketing Status: Prescription
20MG/PACKET
Marketing Status: Prescription
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)
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
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)
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
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
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