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CARVEDILOL از شرکت RUBICON

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CARVEDILOL از شرکت RUBICON

Abbreviated New Drug Application (ANDA): 078165

Company: RUBICON

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/2007/078165s000_ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/11/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/26/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/16/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/16/2007 SUPPL-1 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 WOODWARD

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 WOODWARD

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 WOODWARD

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 WOODWARD
بخوانید  CARVEDILOL از شرکت ZYDUS PHARMS USA INC
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