Details for New Drug Application (NDA): 078969
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NDA 078969 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Norvium Bioscience, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in forty-six NDAs. It is available from six 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078969
| Tradename: | GRANISETRON HYDROCHLORIDE |
| Applicant: | Natco Pharma |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078969
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078969
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078969 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-735 | 51991-735-20 | 2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK |
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078969 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-735 | 51991-735-32 | 1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jun 22, 2009 | TE: | AB | RLD: | No | ||||
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