Details for New Drug Application (NDA): 210826
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NDA 210826 describes LEVOMILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc, and is included in four NDAs. It is available from one supplier. Additional details are available on the LEVOMILNACIPRAN HYDROCHLORIDE profile page.
The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 210826
| Tradename: | LEVOMILNACIPRAN HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | levomilnacipran hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jan 6, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Jan 6, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 80MG BASE | ||||
| Approval Date: | Jan 6, 2023 | TE: | RLD: | No | |||||
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