DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 206528
NDA 206528 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Bio-pharm Inc, Macleods Pharms Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, Upsher-smith Labs, and Wockhardt Ltd, and is included in thirty-two NDAs. It is available from thirty-six suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.
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.
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 | ||||
Complete Access Available with Subscription
