Details for New Drug Application (NDA): 205242
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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 205242
Tradename: | GEMCITABINE HYDROCHLORIDE |
Applicant: | Mylan Labs Ltd |
Ingredient: | gemcitabine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205242
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 205242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 205242 | ANDA | Mylan Institutional LLC | 67457-616 | 67457-616-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE |
GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 205242 | ANDA | Mylan Institutional LLC | 67457-617 | 67457-617-30 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-617-30) / 26.3 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: | Dec 6, 2017 | 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: | Dec 6, 2017 | 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: | Dec 6, 2017 | TE: | AP | RLD: | No |
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