Details for New Drug Application (NDA): 208328
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NDA 208328 describes MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Amneal, Ani Pharms, Macleods Pharms Ltd, and Xiamen Lp Pharm Co, and is included in four NDAs. It is available from five suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE profile page.
The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 208328
| Tradename: | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
| Applicant: | Amneal |
| Ingredient: | donepezil hydrochloride; memantine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208328
| Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 208328
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208328 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1247 | 69238-1247-3 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-3) |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208328 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1247 | 69238-1247-9 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;14MG | ||||
| Approval Date: | Jan 27, 2017 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 15, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;28MG | ||||
| Approval Date: | Jan 27, 2017 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 15, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;7MG | ||||
| Approval Date: | Feb 27, 2025 | TE: | AB | RLD: | No | ||||
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