Details for New Drug Application (NDA): 020509
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The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are thirty drug master file entries 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 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
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 | ||||
Approval Date: | May 15, 1996 | TE: | RLD: | Yes |
Expired US Patents for NDA 020509
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | See Plans and Pricing | See Plans and Pricing |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | See Plans and Pricing | See Plans and Pricing |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | See Plans and Pricing | See Plans and Pricing |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | See Plans and Pricing | See Plans and Pricing |
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