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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078139
Company: MYLAN

Products on ANDA 078139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2007	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
01/31/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/31/2023	SUPPL-15	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.
03/31/2017	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/07/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/27/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078139

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090469	AUROBINDO PHARMA
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077406	CHARTWELL MOLECULES
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078152	GLENMARK PHARMS LTD
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	209389	IPCA LABS LTD
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078139	MYLAN
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078050	SANDOZ
ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077557	SUN PHARM INDS

TABLET, ORALLY DISINTEGRATING;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090469	AUROBINDO PHARMA
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077406	CHARTWELL MOLECULES
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078152	GLENMARK PHARMS LTD
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	209389	IPCA LABS LTD
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078139	MYLAN
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078050	SANDOZ
ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077557	SUN PHARM INDS

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