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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077463
Company: STRIDES PHARMA INTL

Products on ANDA 077463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	AB	No	No
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2009	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2022	SUPPL-12	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/13/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/13/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/30/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/30/2013	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 077463

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf

Therapeutic Equivalents for ANDA 077463

NATEGLINIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	206432	CADILA PHARMS LTD
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077461	DR REDDYS LABS LTD
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	205544	RISING
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077463	STRIDES PHARMA INTL
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077462	WATSON LABS
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	205248	ZYDUS PHARMS

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	206432	CADILA PHARMS LTD
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077461	DR REDDYS LABS LTD
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	205544	RISING
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077463	STRIDES PHARMA INTL
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077462	WATSON LABS
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	205248	ZYDUS PHARMS

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