Details for New Drug Application (NDA): 202997
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The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 202997
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
Approval Date: | May 7, 2013 | TE: | AP | RLD: | No |
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