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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091032
Company: HIKMA FARMACEUTICA

Products on ANDA 091032

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091032

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2010	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
01/02/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091032

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION; 40MG/2ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020571	PFIZER INC
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079068	ACCORD HLTHCARE
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078589	ACTAVIS TOTOWA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090726	EPIC PHARMA LLC
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213278	EUGIA PHARMA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077776	FRESENIUS KABI USA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	212993	GLAND PHARMA LTD
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090675	HENGRUI PHARMA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091032	HIKMA FARMACEUTICA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090016	HISUN PHARM HANGZHOU
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077915	HOSPIRA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203054	INTAS PHARMS USA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206935	NOVAST LABS
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203380	QILU PHARM HAINAN
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208718	SHILPA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078753	WEST-WARD PHARMS INT
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090393	ZENNOVA

INJECTABLE;INJECTION; 100MG/5ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020571	PFIZER INC
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079068	ACCORD HLTHCARE
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078589	ACTAVIS TOTOWA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090726	EPIC PHARMA LLC
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213278	EUGIA PHARMA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077776	FRESENIUS KABI USA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	212993	GLAND PHARMA LTD
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090675	HENGRUI PHARMA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091032	HIKMA FARMACEUTICA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090016	HISUN PHARM HANGZHOU
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077915	HOSPIRA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203054	INTAS PHARMS USA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206935	NOVAST LABS
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203380	QILU PHARM HAINAN
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208718	SHILPA
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078753	WEST-WARD PHARMS INT
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090393	ZENNOVA

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