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Details for New Drug Application (NDA): 078522
NDA 078522 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, Natco Pharma, Orchid Hlthcare, Taro Pharm, and Teva Pharms, and is included in forty-four NDAs. It is available from eighteen suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.
The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078522
| Tradename: | GRANISETRON HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Antiemetics |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078522
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078522
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 078522 | ANDA | Fresenius Kabi USA, LLC | 63323-317 | N | 63323-317-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | ||||
| Approval Date: | Dec 31, 2007 | TE: | AP | RLD: | No | ||||
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