Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207252
Company: JIANGSU HENGRUI MED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/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
08/09/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207252Orig1s000ltr.pdf

DOCETAXEL

INJECTABLE;INJECTION; 20MG/ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 80MG/4ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 160MG/8ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English