Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090393
Company: ZENNOVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 20MG/ML INJECTABLE; INJECTION Prescription None No No
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/13/2011 ORIG-1 Approval

Label is not available on this site.

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 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 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 090675 JIANGSU HENGRUI MED
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
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 090101 TEVA PHARMS USA
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 AKORN
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 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 090675 JIANGSU HENGRUI MED
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
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 090101 TEVA PHARMS USA
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English