Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 209604
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/2ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1.5GM/15ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/20ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/03/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209604Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209604Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604s003ltr.pdf
12/18/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s002lbl.pdf
07/30/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf
08/03/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English