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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077406
Company: CHARTWELL MOLECULES

Products on ANDA 077406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON	ONDANSETRON	16MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	No	Yes
ONDANSETRON	ONDANSETRON	24MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	No	Yes
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 077406

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			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077406s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/04/2008	SUPPL-4	Labeling		Label is not available on this site.
10/31/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077406

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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