Details for New Drug Application (NDA): 206310
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NDA 206310 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Ph Health, Rising, Sun Pharm, Vitruvias, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Sciegen Pharms Inc, Seton Pharms, Ajanta Pharma Ltd, Alembic, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Pointview Hldings, Polygen Pharms, Puracap Pharm Llc, Somerset Theraps Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, Zydus Lifesciences, Amneal, and Xiamen Lp Pharm Co, and is included in forty-seven NDAs. It is available from thirty-nine 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-two drug master file entries for this compound. Six 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-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 206310
| Tradename: | MEMANTINE HYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | memantine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 206310
| Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 206310
Suppliers and Packaging for NDA: 206310
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206310 | ANDA | Macleods Pharmaceuticals Limited | 33342-219 | 33342-219-07 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-219-07) |
| MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206310 | ANDA | Macleods Pharmaceuticals Limited | 33342-219 | 33342-219-12 | 10 BLISTER PACK in 1 CARTON (33342-219-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 7MG | ||||
| Approval Date: | Aug 28, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 14MG | ||||
| Approval Date: | Aug 28, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 21MG | ||||
| Approval Date: | Aug 28, 2025 | TE: | AB | RLD: | No | ||||
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