Details for New Drug Application (NDA): 090242
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The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 090242
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090242
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 090242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 090242 | ANDA | Fresenius Kabi USA, LLC | 63323-126 | 63323-126-03 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03) / 50 mL in 1 VIAL, SINGLE-DOSE |
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 090242 | ANDA | Fresenius Kabi USA, LLC | 63323-126 | 63323-126-00 | 1 VIAL in 1 CARTON (63323-126-00) / 50 mL in 1 VIAL |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
Approval Date: | May 16, 2011 | TE: | AP | RLD: | No |
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