Details for New Drug Application (NDA): 205081
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NDA 205081 describes MILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms and Uspharma Windlas and is included in two NDAs. It is available from one supplier. Additional details are available on the MILNACIPRAN HYDROCHLORIDE profile page.
The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for 205081
| Tradename: | MILNACIPRAN HYDROCHLORIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | milnacipran hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205081
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 205081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081 | ANDA | Amneal Pharmaceuticals LLC | 65162-091 | 65162-091-06 | 60 TABLET in 1 BOTTLE (65162-091-06) |
| MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081 | ANDA | Amneal Pharmaceuticals LLC | 65162-092 | 65162-092-06 | 60 TABLET in 1 BOTTLE (65162-092-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | RLD: | No | |||||
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