Details for New Drug Application (NDA): 210383
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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 210383
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Novast Labs |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210383
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 210383
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 210383 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-496 | 50742-496-26 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) / 26.3 mL in 1 VIAL, SINGLE-DOSE |
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 210383 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-497 | 50742-497-53 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/5.26ML (38MG/ML) | ||||
Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/26.3ML (38MG/ML) | ||||
Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/52.6ML (38MG/ML) | ||||
Approval Date: | Feb 14, 2019 | TE: | AP | RLD: | No |
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