Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020075

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LIORESAL (BACLOFEN)
0.05MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LIORESAL
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.05MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020075
Product Number: 003
Approval Date: Nov 7, 1996
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIORESAL (BACLOFEN)
0.5MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LIORESAL
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020075
Product Number: 001
Approval Date: Jun 17, 1992
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIORESAL (BACLOFEN)
2MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: LIORESAL
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020075
Product Number: 002
Approval Date: Jun 17, 1992
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information