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Abbreviated New Drug Application (ANDA): 207252
Company: HENGRUI PHARMA
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 209640 AMNEAL
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 HENGRUI PHARMA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204490 HIKMA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 205934 SHILPA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 210327 SHILPA
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 209640 AMNEAL
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 HENGRUI PHARMA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204490 HIKMA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 205934 SHILPA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 210327 SHILPA
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 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 HENGRUI PHARMA
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 208137 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 205934 SHILPA
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 210327 SHILPA
TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US
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