Details for New Drug Application (NDA): 090961
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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 090961
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Zydus Lifesciences |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090961
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090961
Suppliers and Packaging for NDA: 090961
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090961 | ANDA | A-S Medication Solutions | 50090-6291 | 50090-6291-0 | 60 TABLET in 1 BOTTLE (50090-6291-0) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090961 | ANDA | A-S Medication Solutions | 50090-6291 | 50090-6291-1 | 90 TABLET in 1 BOTTLE (50090-6291-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 10, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 10, 2017 | TE: | AB | RLD: | No |
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