Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078288
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/22/2013 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
12/08/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/08/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206846 ACCORD HLTHCARE
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 202599 AUROBINDO PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078288 BAXTER HLTHCARE CORP
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090424 EMCURE PHARMS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076974 FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079224 GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090648 GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076781 HIKMA FARMACEUTICA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077473 HOSPIRA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077840 HOSPIRA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204906 MYLAN LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203711 QILU PHARM CO LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077430 SANDOZ INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076876 TEVA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076967 WEST-WARD PHARMS INT
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077365 WEST-WARD PHARMS INT
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077577 WOCKHARDT
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206845 ACCORD HLTHCARE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 202600 AUROBINDO PHARMA LTD
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078287 BAXTER HLTHCARE CORP
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078945 EMCURE PHARMS LTD
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076972 FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 202253 FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077548 HOSPIRA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077551 SANDOZ INC
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077011 WEST-WARD PHARMS INT
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077541 WEST-WARD PHARMS INT
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077716 WOCKHARDT

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