Details for New Drug Application (NDA): 077406
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The generic ingredient in ONDANSETRON 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 077406
Tradename: | ONDANSETRON |
Applicant: | Chartwell Molecules |
Ingredient: | ondansetron |
Patents: | 0 |
Pharmacology for NDA: 077406
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077406
Suppliers and Packaging for NDA: 077406
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 077406 | ANDA | Chartwell RX, LLC | 62135-121 | 62135-121-30 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-121-30) |
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 077406 | ANDA | Chartwell RX, LLC | 62135-122 | 62135-122-30 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-122-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 16MG | ||||
Approval Date: | Dec 26, 2006 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 24MG | ||||
Approval Date: | Dec 26, 2006 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG | ||||
Approval Date: | Dec 26, 2006 | TE: | AB | RLD: | No |
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