Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078167
Company: SANDOZ INC
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
12/26/2007 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
10/14/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

08/30/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/13/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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 205720 ACCORD HLTHCARE
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 078167 SANDOZ INC
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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