Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077346
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Discontinued None No No
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Discontinued None No No
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Discontinued None No No
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Discontinued 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
09/05/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077346s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/01/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

06/01/2016 SUPPL-29 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/10/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-11 Labeling-Patient Package Insert

Label is not available on this site.

01/31/2011 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-5 Labeling

Label is not available on this site.

01/15/2009 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/05/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English