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Details for New Drug Application (NDA): 078678
» See Plans and Pricing
NDA 078678 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, Puniska, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Yung Shin Pharm, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma, Mylan, Natco Pharma, Orchid Hlthcare, Taro, and Teva Pharms, and is included in forty-six NDAs. It is available from twelve 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078678
| Tradename: | GRANISETRON HYDROCHLORIDE |
| Applicant: | Orchid Hlthcare |
| 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 | Northstar Rx LLC | 16714-221 | 16714-221-01 | 20 TABLET, FILM COATED in 1 BOTTLE (16714-221-01) |
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078678 | ANDA | Northstar Rx LLC | 16714-221 | 16714-221-30 | 2 BLISTER PACK in 1 CARTON (16714-221-30) > 1 TABLET, FILM COATED in 1 BLISTER PACK (16714-221-10) |
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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