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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077574
Company: FRESENIUS KABI USA

Products on ANDA 077574

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2006	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
04/04/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/04/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/04/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/14/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/15/2011	SUPPL-10	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
07/08/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/17/2009	SUPPL-7	Labeling		Label is not available on this site.
04/20/2015	SUPPL-5	Labeling		Label is not available on this site.
05/14/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077574

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 PHARMA LTD
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

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