Details for New Drug Application (NDA): 205147
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NDA 205147 describes MILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, and Oryza, and is included in three 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 205147
| Tradename: | MILNACIPRAN HYDROCHLORIDE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | milnacipran hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Oct 3, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 3, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 3, 2024 | TE: | AB | RLD: | No | ||||
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