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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077915
Company: HOSPIRA

Products on ANDA 077915

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 077915

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2008	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
05/15/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/15/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/19/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/19/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/19/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/02/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/24/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077915

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
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078753	HIKMA
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	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	090393	PHARMOBEDIENT
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

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
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078753	HIKMA
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	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	090393	PHARMOBEDIENT
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

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