Details for New Drug Application (NDA): 210587
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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 210587
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Polygen Pharms |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210587
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 210587
Suppliers and Packaging for NDA: 210587
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 210587 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-071 | 52605-071-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (52605-071-10) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 210587 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-071 | 52605-071-13 | 30 TABLET, FILM COATED in 1 BOTTLE (52605-071-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 11, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 11, 2020 | TE: | AB | RLD: | No |
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