Details for New Drug Application (NDA): 077851
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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 077851
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Natco Pharma Ltd |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 077851
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 077851
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 077851 | ANDA | ACTAVIS PHARMA, INC. | 45963-538 | 45963-538-30 | 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30) |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 077851 | ANDA | ACTAVIS PHARMA, INC. | 45963-539 | 45963-539-30 | 30 TABLET, FILM COATED in 1 BOTTLE (45963-539-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jun 25, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Jun 25, 2007 | TE: | AB | RLD: | No |
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