Details for New Drug Application (NDA): 205365
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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 205365
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Ani Pharms |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205365
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205365
Suppliers and Packaging for NDA: 205365
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205365 | ANDA | Bryant Ranch Prepack | 63629-2142 | 63629-2142-1 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2142-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 7MG | ||||
Approval Date: | Feb 28, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 14MG | ||||
Approval Date: | Feb 28, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 21MG | ||||
Approval Date: | Feb 28, 2020 | TE: | RLD: | No |
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