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Details for New Drug Application (NDA): 020509
NDA 020509 describes GEMZAR, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the GEMZAR profile page.
The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Nineteen 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 are thirty drug master file entries for this compound. Nineteen 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 |
Pharmacology for NDA: 020509
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 020509
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509 | NDA | Eli Lilly and Company | 0002-7501 | 0002-7501-01 | 5 mL in 1 VIAL, SINGLE-DOSE (0002-7501-01) |
| GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509 | NDA | Eli Lilly and Company | 0002-7502 | 0002-7502-01 | 25 mL in 1 VIAL, SINGLE-DOSE (0002-7502-01) |
Paragraph IV (Patent) Challenges for 020509
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GEMZAR | INJECTABLE;INJECTION | gemcitabine hydrochloride | 020509 | 2005-11-14 |
| GEMZAR | INJECTABLE;INJECTION | gemcitabine hydrochloride | 020509 | 2005-11-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | May 15, 1996 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | May 15, 1996 | TE: | AP | 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 | Start Trial | Start Trial |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | Start Trial | Start Trial |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | Start Trial | Start Trial |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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