Details for New Drug Application (NDA): 202063
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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 202063
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Emcure Pharms Ltd |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
Approval Date: | Sep 11, 2012 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Sep 11, 2012 | TE: | RLD: | No |
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