Details for New Drug Application (NDA): 090073
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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 090073
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Allied |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090073
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090073
Suppliers and Packaging for NDA: 090073
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090073 | ANDA | Bryant Ranch Prepack | 71335-1863 | 71335-1863-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1863-1) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090073 | ANDA | Bryant Ranch Prepack | 71335-1863 | 71335-1863-2 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1863-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 4, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 4, 2015 | TE: | AB | RLD: | No |
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