Details for New Drug Application (NDA): 020239
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NDA 020239 describes KYTRIL, which is a drug marketed by Roche and is included in three NDAs. Additional details are available on the KYTRIL profile page.
The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 020239
| Tradename: | KYTRIL |
| Applicant: | Roche |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 29, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 11, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 17, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020239
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-001 | Dec 29, 1993 | 6,294,548 | ⤷ Get Started Free |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-003 | Sep 17, 2004 | 4,886,808 | ⤷ Get Started Free |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-002 | Mar 11, 1994 | 4,886,808 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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