Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075184
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/25/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075184_paclitaxel_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/10/2015 SUPPL-16 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/28/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/10/2008 SUPPL-10 Labeling

Label is not available on this site.

05/20/2008 SUPPL-9 Labeling

Label is not available on this site.

10/23/2002 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Prntlbl.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
PACITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 207326 GLAND PHARMA LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 090130 ACTAVIS TOTOWA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 077574 FRESENIUS KABI USA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 076131 HOSPIRA
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 091540 MYLAN LABS LTD
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075184 TEVA PHARMS
PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription No AP 075190 WEST-WARD PHARMS INT
TAXOL PACLITAXEL 6MG/ML INJECTABLE;INJECTION Prescription Yes AP 020262 HQ SPCLT PHARMA

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