Details for New Drug Application (NDA): 090469
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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 090469
Tradename: | ONDANSETRON |
Applicant: | Aurobindo Pharma |
Ingredient: | ondansetron |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090469
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090469
Suppliers and Packaging for NDA: 090469
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 090469 | ANDA | NorthStar Rx LLC | 16714-200 | 16714-200-30 | 3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10) |
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 090469 | ANDA | NorthStar Rx LLC | 16714-201 | 16714-201-10 | 1 BLISTER PACK in 1 CARTON (16714-201-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG | ||||
Approval Date: | Apr 12, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 8MG | ||||
Approval Date: | Apr 12, 2010 | TE: | AB | RLD: | No |
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