Details for New Drug Application (NDA): 077557
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The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077557
Tradename: | ONDANSETRON |
Applicant: | Sun Pharm Inds |
Ingredient: | ondansetron |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077557
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077557
Suppliers and Packaging for NDA: 077557
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 077557 | ANDA | Quality Care Products LLC | 35356-197 | 35356-197-65 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (35356-197-65) |
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 077557 | ANDA | A-S Medication Solutions | 50090-5346 | 50090-5346-0 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-5346-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG | ||||
Approval Date: | Aug 2, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 8MG | ||||
Approval Date: | Aug 2, 2007 | TE: | AB | RLD: | No |
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