Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076131
Company: HOSPIRA

Products on ANDA 076131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2002	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-30	Labeling-Container/Carton Labels		Label is not available on this site.
01/09/2013	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076131s022lbl.pdf
03/23/2007	SUPPL-12	Labeling		Label is not available on this site.
03/07/2007	SUPPL-9	Labeling		Label is not available on this site.

Labels for ANDA 076131

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/09/2013	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076131s022lbl.pdf

Therapeutic Equivalents for ANDA 076131

PACLITAXEL

INJECTABLE;INJECTION; 6MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205720	ACCORD HLTHCARE
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090130	ACTAVIS TOTOWA
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216874	ALEMBIC
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077574	FRESENIUS KABI USA
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207326	GLAND
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075190	HIKMA
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076131	HOSPIRA
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213434	MSN
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075184	TEVA PHARMS