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Details for New Drug Application (NDA): 206528
The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-one 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 206528
Tradename: | MEMANTINE HYDROCHLORIDE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Therapeutic Class: | Antidementia Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206528
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 206528
Suppliers and Packaging for NDA: 206528
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 206528 | ANDA | Ajanta Pharma Limited | 27241-070 | N | 27241-070-06 |
MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 206528 | ANDA | Ajanta Pharma Limited | 27241-071 | N | 27241-071-06 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 30, 2015 | TE: | AB | RLD: | No |
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