Details for New Drug Application (NDA): 090051
✉ Email this page to a colleague
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 090051
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Lupin Ltd |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090051
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090051
Suppliers and Packaging for NDA: 090051
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090051 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-229 | 68180-229-07 | 60 TABLET, FILM COATED in 1 BOTTLE (68180-229-07) |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090051 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-230 | 68180-230-07 | 60 TABLET, FILM COATED in 1 BOTTLE (68180-230-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 10, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 10, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription