Details for New Drug Application (NDA): 206028
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NDA 206028 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-four NDAs. It is available from thirty-eight 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. 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-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 206028
| Tradename: | MEMANTINE HYDROCHLORIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | memantine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 206028
| Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 206028
Suppliers and Packaging for NDA: 206028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206028 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8264 | 0615-8264-39 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39) |
| MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206028 | ANDA | Major Pharmaceuticals | 0904-6734 | 0904-6734-61 | 100 BLISTER PACK in 1 CARTON (0904-6734-61) / 1 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: | Sep 28, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 14MG | ||||
| Approval Date: | Sep 28, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 21MG | ||||
| Approval Date: | Sep 28, 2016 | TE: | AB | RLD: | No | ||||
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