Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212378

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BACLOFEN (BACLOFEN)
5MG
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212378
Product Number: 003
Approval Date: Apr 30, 2021
Applicant Holder Full Name: INNOGENIX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BACLOFEN (BACLOFEN)
10MG
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212378
Product Number: 001
Approval Date: Oct 9, 2020
Applicant Holder Full Name: INNOGENIX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BACLOFEN (BACLOFEN)
20MG
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212378
Product Number: 002
Approval Date: Oct 9, 2020
Applicant Holder Full Name: INNOGENIX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information