Details for New Drug Application (NDA): 213614
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NDA 213614 describes ALOSETRON HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Endo Operations, Eywa Pharma, Hikma, Mankind Pharma, and Rising, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ALOSETRON HYDROCHLORIDE profile page.
The generic ingredient in ALOSETRON HYDROCHLORIDE is alosetron hydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.
The generic ingredient in ALOSETRON HYDROCHLORIDE is alosetron hydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.
Summary for 213614
| Tradename: | ALOSETRON HYDROCHLORIDE |
| Applicant: | Mankind Pharma |
| Ingredient: | alosetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213614
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 213614
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 213614 | ANDA | Bryant Ranch Prepack | 63629-2518 | 63629-2518-1 | 30 TABLET in 1 BOTTLE (63629-2518-1) |
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 213614 | ANDA | Lifestar Pharma LLC | 70756-701 | 70756-701-30 | 30 TABLET in 1 BOTTLE (70756-701-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No | ||||
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