Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205934
Company: SHILPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes 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
12/22/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205934Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205934Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2021 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205934Orig1s005ltr.pdf
02/19/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205934Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/04/2021 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf
08/04/2021 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf
02/19/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf
12/22/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.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 LABS LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204490 HIKMA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU PHARMS
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 LABS LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204490 HIKMA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU PHARMS
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 JIANGSU PHARMS
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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