Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203380
Company: QILU PHARM CO LTD
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
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/03/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203380Orig1s000ltr.pdf

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 AKORN
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077219 CIPLA LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 200771 EMCURE PHARMS LTD
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 078188 FRESENIUS KABI USA
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 206935 INGENUS PHARMS LLC
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 090675 JIANGSU HENGRUI MED
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090393 MUSTAFA NEVZAT ILAC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078953 NEOPHARMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078122 PLIVA LACHEMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 208718 SHILPA MEDICARE LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090101 TEVA PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078753 WEST-WARD PHARMS INT

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 AKORN
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077219 CIPLA LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 200771 EMCURE PHARMS LTD
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 078188 FRESENIUS KABI USA
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 206935 INGENUS PHARMS LLC
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 090675 JIANGSU HENGRUI MED
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090393 MUSTAFA NEVZAT ILAC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078953 NEOPHARMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078122 PLIVA LACHEMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 208718 SHILPA MEDICARE LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090101 TEVA PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078753 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 300MG/15ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020571 PFIZER INC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD

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