Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209604
Company: ACCORD HLTHCARE
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 |
---|---|---|---|---|---|
06/25/2019 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209604s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209604Orig1s004ltr.pdf | |
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 |
---|---|---|---|---|---|
06/25/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209604s004lbl.pdf | |
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 |