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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077365
Company: HIKMA
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 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
12/26/2006 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
08/16/2021 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/16/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/19/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/19/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-4 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 077577 ATLANTIDE
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 076967 HIKMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077365 HIKMA
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 203711 QILU PHARM HAINAN
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 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 077716 ATLANTIDE
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 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 077011 HIKMA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077541 HIKMA
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
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