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Generated: May 28, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
| 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 (0002-7501-01) |
GEMZAR |
gemcitabine hydrochloride |
INJECTABLE;INJECTION | 020509 | NDA | Eli Lilly and Company | 0002-7502 | 0002-7502-01 | 25 mL in 1 VIAL (0002-7502-01) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | May 15, 1996 | TE: | AP | RLD: | Yes | ||||
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | May 15, 1996 | TE: | AP | RLD: | Yes | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | 4,808,614*PED | ► Subscribe | ||||||||||||||||||||||
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | 4,808,614*PED | ► Subscribe | ||||||||||||||||||||||
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | 5,464,826*PED | ► Subscribe | ||||||||||||||||||||||
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | 5,464,826*PED | ► Subscribe | ||||||||||||||||||||||
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