Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022462

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

Active Ingredient: BACLOFEN
Proprietary Name: GABLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.05MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022462
Product Number: 001
Approval Date: Nov 19, 2010
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: BACLOFEN
Proprietary Name: GABLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022462
Product Number: 002
Approval Date: Nov 19, 2010
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GABLOFEN (BACLOFEN)
1MG/ML
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: GABLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022462
Product Number: 004
Approval Date: Jun 22, 2012
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: BACLOFEN
Proprietary Name: GABLOFEN
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022462
Product Number: 003
Approval Date: Nov 19, 2010
Applicant Holder Full Name: PIRAMAL CRITICAL CARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information