Details for New Drug Application (NDA): 206647
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NDA 206647 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 206647
| Tradename: | ALOSETRON HYDROCHLORIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | alosetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 206647
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 206647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 206647 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-248 | 53746-248-30 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30) |
| ALOSETRON HYDROCHLORIDE | alosetron hydrochloride | TABLET;ORAL | 206647 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-249 | 53746-249-30 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-249-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Dec 22, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Dec 22, 2016 | TE: | AB | RLD: | No | ||||
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