Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076989
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription AB No No
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription AB No No
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription AB No No
CARVEDILOL CARVEDILOL 25MG 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
09/05/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076989s000_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/13/2008 SUPPL-2 Labeling

Label is not available on this site.

CARVEDILOL

TABLET;ORAL; 3.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077474 CHARTWELL MOLECULAR
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078165 RUBICON
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 3.125MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 6.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077474 CHARTWELL MOLECULAR
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078165 RUBICON
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 6.25MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077474 CHARTWELL MOLECULAR
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078165 RUBICON
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 12.5MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077474 CHARTWELL MOLECULAR
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078165 RUBICON
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 25MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

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