Details for New Drug Application (NDA): 078139
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The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078139
Tradename: | ONDANSETRON |
Applicant: | Mylan |
Ingredient: | ondansetron |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078139
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078139
Suppliers and Packaging for NDA: 078139
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078139 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7732 | 0378-7732-93 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-7732-93) |
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078139 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7734 | 0378-7734-93 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-7734-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG | ||||
Approval Date: | Jun 25, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 8MG | ||||
Approval Date: | Jun 25, 2007 | TE: | AB | RLD: | No |
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