Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077463
Company: PAR PHARM
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
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
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.

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

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 205055 ALVOGEN MALTA
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 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205248 ZYDUS PHARMS
STARLIX NATEGLINIDE 60MG TABLET;ORAL Prescription Yes AB 021204 NOVARTIS

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 205055 ALVOGEN MALTA
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 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205248 ZYDUS PHARMS
STARLIX NATEGLINIDE 120MG TABLET;ORAL Prescription Yes AB 021204 NOVARTIS

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