Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076131
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
05/08/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/05/2023 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/09/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076131s022lbl.pdf | |
03/23/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/07/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/09/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076131s022lbl.pdf |
PACLITAXEL
INJECTABLE;INJECTION; 6MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205720 | ACCORD HLTHCARE |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090130 | ACTAVIS TOTOWA |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216874 | ALEMBIC |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077574 | FRESENIUS KABI USA |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207326 | GLAND PHARMA LTD |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075190 | HIKMA |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076131 | HOSPIRA |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213434 | MSN |
PACLITAXEL | PACLITAXEL | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075184 | TEVA PHARMS |