Details for New Drug Application (NDA): 209180
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NDA 209180 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 209180
| Tradename: | ALOSETRON HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | alosetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209180
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 209180
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 209180 | ANDA | Rising Pharmaceuticals, Inc. | 64980-453 | 64980-453-03 | 30 TABLET in 1 BOTTLE (64980-453-03) |
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 209180 | ANDA | Rising Pharmaceuticals, Inc. | 64980-453 | 64980-453-50 | 500 TABLET in 1 BOTTLE (64980-453-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Jan 14, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jan 14, 2019 | TE: | AB | RLD: | No | ||||
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