Details for New Drug Application (NDA): 209604
NDA 209604 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Adaptis, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Pharmobedient, Sagent Pharms, Sagent Pharms Inc, Sun Pharm, Teva Pharms, and Teyro Labs, and is included in thirty NDAs. It is available from ten suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 209604
| Tradename: | GEMCITABINE HYDROCHLORIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | gemcitabine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/2ML (100MG/ML) | ||||
| Approval Date: | Aug 3, 2017 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/10ML (100MG/ML) | ||||
| Approval Date: | Aug 3, 2017 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.5GM/15ML (100MG/ML) | ||||
| Approval Date: | Aug 3, 2017 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
