Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077337
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 2MG BASE TABLET;ORAL Prescription None No No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 4MG BASE TABLET;ORAL Prescription None No No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 2MG BASE TABLET;ORAL Prescription None No No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 4MG BASE TABLET;ORAL Prescription None No Yes
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 1MG BASE TABLET;ORAL Prescription None 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
05/19/2017 ORIG-2 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/077337Orig1s000lbl.pdf
05/07/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077337Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077337Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/077337Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/19/2017 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/077337Orig1s000lbl.pdf
05/07/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077337Orig1s000lbl.pdf

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