Details for New Drug Application (NDA): 078678
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The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078678
Tradename: | GRANISETRON HYDROCHLORIDE |
Applicant: | Orbion Pharms |
Ingredient: | granisetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078678
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078678
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078678 | ANDA | Bionpharma Inc. | 69452-350 | 69452-350-01 | 2 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078678 | ANDA | Bionpharma Inc. | 69452-350 | 69452-350-11 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Feb 13, 2008 | TE: | AB | RLD: | No |
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