Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216338
Company: TEVA PHARMS INC
Company: TEVA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/11/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216338Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216338Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/21/2023 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216338Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/21/2023 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s001lbl.pdf | |
05/11/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s000lbl.pdf |
PACLITAXEL
POWDER;INTRAVENOUS; 100MG/VIAL
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ABRAXANE | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 021660 | BRISTOL-MYERS |
PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 211875 | AM REGENT |
PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 216338 | TEVA PHARMS INC |