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Details for New Drug Application (NDA): 202031
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 202031
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Luitpold Pharms Inc |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
Approval Date: | May 7, 2013 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | May 7, 2013 | TE: | AP | RLD: | No |
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