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Product Details for ANDA 208328

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MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;7MG
Marketing Status: Prescription

Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;7MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208328
Product Number: 003
Approval Date: Feb 27, 2025
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;14MG
Marketing Status: Prescription

Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;14MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208328
Product Number: 001
Approval Date: Jan 27, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;21MG
Marketing Status: Prescription

Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;21MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208328
Product Number: 004
Approval Date: Feb 27, 2025
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE)
10MG;28MG
Marketing Status: Prescription

Active Ingredient: DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Proprietary Name: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG;28MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208328
Product Number: 002
Approval Date: Jan 27, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information