Product Details for ANDA 214651
MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
7MG
Marketing Status: Prescription
14MG
Marketing Status: Prescription
21MG
Marketing Status: Prescription
28MG
Marketing Status: Prescription
7MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 001
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 001
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
14MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 14MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 002
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 14MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 002
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
21MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 21MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 003
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 21MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 003
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
28MG
Marketing Status: Prescription
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 28MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 004
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: MEMANTINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 28MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214651
Product Number: 004
Approval Date: Aug 9, 2021
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information