Details for New Drug Application (NDA): 091365
✉ Email this page to a colleague
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 091365
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091365
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 091365
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 091365 | ANDA | NorthStar Rx LLC | 16714-909 | 16714-909-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 091365 | ANDA | NorthStar Rx LLC | 16714-930 | 16714-930-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
Approval Date: | Jul 25, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Jul 25, 2011 | TE: | AP | RLD: | No |
Complete Access Available with Subscription