0

COREG از شرکت WOODWARD

تصویر پیدا نشد !

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

COREG از شرکت WOODWARD

New Drug Application (NDA): 020297

Company: WOODWARD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COREG CARVEDILOL 25MG TABLET;ORAL Prescription

AB

Yes No
COREG CARVEDILOL 12.5MG TABLET;ORAL Prescription

AB

Yes Yes
COREG CARVEDILOL 6.25MG TABLET;ORAL Prescription

AB

Yes No
COREG CARVEDILOL 3.125MG TABLET;ORAL Prescription

AB

Yes 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
09/14/1995 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020297Orig1s000rev.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2017 SUPPL-38 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020297Orig1s038ltr.pdf

10/02/2015 SUPPL-37 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020297Orig1s037ltr.pdf

07/06/2011 SUPPL-36 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf

01/06/2011 SUPPL-35 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf

01/06/2011 SUPPL-34 Labeling-Patient Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf

01/25/2011 SUPPL-33 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf

12/19/2008 SUPPL-30 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s030ltr.pdf

06/23/2009 SUPPL-29 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020297s029ltr.pdf

07/22/2008 SUPPL-28 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s028ltr.pdf

02/23/2007 SUPPL-22 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020297s022ltr.pdf

12/20/2006 SUPPL-21 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s021ltr.pdf

09/05/2006 SUPPL-20 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s020_ltr.pdf

08/28/2006 SUPPL-18 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s018ltr.pdf

08/16/2005 SUPPL-17 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s017ltr.pdf

04/29/2005 SUPPL-13 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s013ltr.pdf

09/29/2003 SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297slr011ltr.pdf

03/27/2003 SUPPL-9 Efficacy-New Indication

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297se1-009ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-297s009_Coreg.cfm

11/08/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2001 SUPPL-7 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_Approv.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg.cfm

07/10/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/25/2000 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1999 SUPPL-4 Labeling

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20297s4_Coreg.pdf

07/28/1998 SUPPL-3 Labeling

Label is not available on this site.

05/20/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1997 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2017 SUPPL-38

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf
10/02/2015 SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf
07/06/2011 SUPPL-36

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf
01/25/2011 SUPPL-33

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf
01/06/2011 SUPPL-35

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
01/06/2011 SUPPL-34

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
06/23/2009 SUPPL-29

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf
12/19/2008 SUPPL-30

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf
07/22/2008 SUPPL-28

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf
02/23/2007 SUPPL-22

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf
08/28/2006 SUPPL-18

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf
04/29/2005 SUPPL-13

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf
11/01/2001 SUPPL-7

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf

COREG

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

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; 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; 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
بخوانید  ACYCLOVIR از شرکت MYLAN
برچسب‌ها:

نظرات کاربران