Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209634
Company: HONG KONG
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
08/24/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2019 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/13/2019 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 No AP 214575 EUGIA PHARMA
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 213510 GLAND PHARMA LTD
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 209634 HONG KONG
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 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 No AP 214575 EUGIA PHARMA
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 213510 GLAND PHARMA LTD
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 209634 HONG KONG
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 No AP 214575 EUGIA PHARMA
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 213510 GLAND PHARMA LTD
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 209634 HONG KONG
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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