Details for New Drug Application (NDA): 205081
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NDA 205081 describes MILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Breckenridge, and Hetero Labs Ltd V, and is included in three NDAs. It is available from two suppliers. 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. Five 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. Five 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 22, 2016 | TE: | AB | RLD: | No | ||||
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