Details for New Drug Application (NDA): 206846
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The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 206846
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Accord Hlthcare |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 206846
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 206846
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 206846 | ANDA | Accord Healthcare, Inc. | 16729-298 | 16729-298-05 | 20 mL in 1 VIAL (16729-298-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Jul 13, 2015 | TE: | AP | RLD: | No |
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