Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078539
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription AB No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription AB No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription AB 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
07/31/2007 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
03/07/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/07/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/15/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/15/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/17/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/04/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ONDANSETRON HYDROCHLORIDE

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077306 APOTEX
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 203761 IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076930 MYLAN
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077851 NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 077050 SUN PHARM INDS (IN)
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077306 APOTEX
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 203761 IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076930 MYLAN
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077851 NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 077050 SUN PHARM INDS (IN)
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

TABLET;ORAL; EQ 24MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 078539 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077517 CASI PHARMS INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 076183 DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077535 GLENMARK GENERICS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 077112 PLIVA HRVATSKA DOO
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription No AB 076252 TEVA
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Prescription Yes AB 020103 NOVARTIS PHARMS CORP

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