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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208193

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OZOBAX DS (BACLOFEN)
10MG/5ML
Marketing Status: Prescription
Active Ingredient: BACLOFEN
Proprietary Name: OZOBAX DS
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 10MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208193
Product Number: 002
Approval Date: Oct 12, 2023
Applicant Holder Full Name: METACEL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
OZOBAX (BACLOFEN)
5MG/5ML
Marketing Status: Discontinued
Active Ingredient: BACLOFEN
Proprietary Name: OZOBAX
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208193
Product Number: 001
Approval Date: Sep 18, 2019
Applicant Holder Full Name: METACEL PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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