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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075190
Company: HIKMA

Products on ANDA 075190

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 075190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2002	ORIG-1	Approval			Letter (PDF) Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75190ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75190rescind.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075190.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/02/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/20/2005	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075190

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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