Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211659

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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: A211659
Product Number: 003
Approval Date: Apr 17, 2020
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
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: A211659
Product Number: 001
Approval Date: Nov 23, 2018
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information

BACLOFEN (BACLOFEN)
15MG
Marketing Status: Prescription

Active Ingredient: BACLOFEN
Proprietary Name: BACLOFEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211659
Product Number: 004
Approval Date: Feb 13, 2024
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
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: A211659
Product Number: 002
Approval Date: Nov 23, 2018
Applicant Holder Full Name: ZYDUS LIFESCIENCES GLOBAL FZE
Marketing Status:  Prescription
Patent and Exclusivity Information