Details for New Drug Application (NDA): 210319
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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 210319
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Seton Pharms |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210319
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 210319
Suppliers and Packaging for NDA: 210319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | SOLUTION;ORAL | 210319 | ANDA | Seton Pharmaceuticals | 13925-540 | 13925-540-12 | 360 mL in 1 BOTTLE (13925-540-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2MG/ML | ||||
Approval Date: | Aug 31, 2020 | TE: | AA | RLD: | No |
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