Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090130
Company: ACTAVIS TOTOWA

Products on ANDA 090130

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 090130

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2009	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
01/27/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/18/2011	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/14/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090130

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