Details for New Drug Application (NDA): 078629
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NDA 078629 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, Pharmobedient, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Intra Sana Labs, 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-seven NDAs. It is available from seven suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.
The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There is one drug master file entry for this compound. Eight 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078629
| Tradename: | GRANISETRON HYDROCHLORIDE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078629
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 078629 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9744 | 0143-9744-10 | 10 VIAL, SINGLE-USE in 1 PACKAGE (0143-9744-10) / 1 mL in 1 VIAL, SINGLE-USE (0143-9744-01) |
| GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 078629 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9745 | 0143-9745-05 | 5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Dec 23, 2009 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Dec 23, 2009 | TE: | AP | RLD: | No | ||||
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