Details for New Drug Application (NDA): 090244
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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 090244
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Chartwell |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090244
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090244
Suppliers and Packaging for NDA: 090244
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090244 | ANDA | Chartwell RX, LLC | 62135-895 | 62135-895-60 | 60 TABLET in 1 BOTTLE (62135-895-60) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090244 | ANDA | Chartwell RX, LLC | 62135-896 | 62135-896-60 | 60 TABLET in 1 BOTTLE (62135-896-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 11, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 11, 2018 | TE: | RLD: | No |
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