Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207563
Company: INGENUS PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/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
08/31/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207563Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/06/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

DOCETAXEL

INJECTABLE;INJECTION; 20MG/2ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 210072 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 210848 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 208859 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

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