Details for New Drug Application (NDA): 078152
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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 078152
Tradename: | ONDANSETRON |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | ondansetron |
Patents: | 0 |
Pharmacology for NDA: 078152
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078152
Suppliers and Packaging for NDA: 078152
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078152 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-273 | 43063-273-04 | 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-273-04) |
ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078152 | ANDA | A-S Medication Solutions | 50090-1658 | 50090-1658-0 | 1 BLISTER PACK in 1 PACKET (50090-1658-0) / 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: | Jun 27, 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 27, 2007 | TE: | AB | RLD: | No |
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