Details for New Drug Application (NDA): 213985
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The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 213985
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Xiamen Lp Pharm Co |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213985
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 213985
Suppliers and Packaging for NDA: 213985
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 213985 | ANDA | Vitruvias Therapeutics, Inc. | 69680-161 | 69680-161-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-161-30) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 213985 | ANDA | Vitruvias Therapeutics, Inc. | 69680-162 | 69680-162-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-162-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 7MG | ||||
Approval Date: | Oct 11, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 14MG | ||||
Approval Date: | Oct 11, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 28MG | ||||
Approval Date: | Oct 11, 2022 | TE: | AB | RLD: | No |
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