Details for New Drug Application (NDA): 020509
NDA 020509 describes GEMZAR, which is a drug marketed by Lilly and is included in one NDA. Additional details are available on the GEMZAR profile page.
The generic ingredient in GEMZAR is gemcitabine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
The generic ingredient in GEMZAR is gemcitabine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 020509
| Tradename: | GEMZAR |
| Applicant: | Lilly |
| Ingredient: | gemcitabine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 15, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 15, 1996 | TE: | RLD: | Yes | |||||
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