Details for New Drug Application (NDA): 078539
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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-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078539
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078539
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078539
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 078539 | ANDA | NorthStar Rx LLC | 16714-159 | 16714-159-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-159-01) |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 078539 | ANDA | NorthStar Rx LLC | 16714-160 | 16714-160-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-160-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jul 31, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Jul 31, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 24MG BASE | ||||
Approval Date: | Jul 31, 2007 | TE: | RLD: | No |
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