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BIAXIN از شرکت ABBVIE

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BIAXIN از شرکت ABBVIE

New Drug Application (NDA): 050698

Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BIAXIN CLARITHROMYCIN 125MG/5ML FOR SUSPENSION;ORAL Discontinued

None

Yes No
BIAXIN CLARITHROMYCIN 250MG/5ML FOR SUSPENSION;ORAL Discontinued

None

Yes No
BIAXIN CLARITHROMYCIN 187MG/5ML FOR SUSPENSION;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
12/23/1993 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2019 SUPPL-41 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050662s061,050698s041,050775s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050662Orig1s061, 050698Orig1s041, 050775Orig1s029ltr.pdf

12/19/2018 SUPPL-40 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s060,050698s040,050775s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050662Orig1s060, 050698Orig1s040, 050775Orig1s028Ltr.pdf

11/25/2018 SUPPL-39 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s059,050698s039,050775s027lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/50662Orig1s059,50698Orig1s039,50775Orig1s027ltr.pdf

06/09/2017 SUPPL-38 Labeling-Package Insert

Label (PDF)

Letter (PDF)

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050662Orig1s058,050698Orig1s038,050775Orig1s026ltr.pdf

10/23/2015 SUPPL-37 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf

01/08/2015 SUPPL-36 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf

07/25/2014 SUPPL-35 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf

10/24/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/26/2016 SUPPL-33 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf

09/09/2013 SUPPL-32 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf

09/09/2013 SUPPL-31 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf

05/03/2012 SUPPL-30 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf

07/05/2012 SUPPL-29 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf

06/01/2012 SUPPL-28 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf

05/27/2011 SUPPL-27 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf

05/03/2012 SUPPL-26 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf

05/27/2011 SUPPL-25 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf

08/14/2009 SUPPL-24 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf

05/22/2008 SUPPL-23 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf

12/18/2007 SUPPL-22 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf

07/05/2006 SUPPL-21 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf

10/04/2005 SUPPL-20 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf

07/19/2004 SUPPL-19 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf

11/21/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2002 SUPPL-14 Efficacy-Accelerated Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50697s002ltr.pdf

06/05/2000 SUPPL-11 Labeling

Label is not available on this site.

09/30/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1997 SUPPL-7 Labeling

Label is not available on this site.

10/23/1995 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/24/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1994 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

08/12/1994 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

08/12/1994 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

07/17/1996 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
09/18/2019 SUPPL-41

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050662s061,050698s041,050775s029lbl.pdf
12/19/2018 SUPPL-40

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s060,050698s040,050775s028lbl.pdf
11/25/2018 SUPPL-39

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s059,050698s039,050775s027lbl.pdf
06/09/2017 SUPPL-38

Labeling-Package Insert

Label (PDF)

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf
05/26/2016 SUPPL-33

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf
10/23/2015 SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf
01/08/2015 SUPPL-36

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf
07/25/2014 SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf
09/09/2013 SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s032lbl.pdf
09/09/2013 SUPPL-31

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s031lbl.pdf
07/05/2012 SUPPL-29

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf
05/03/2012 SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf
05/03/2012 SUPPL-26

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf
05/27/2011 SUPPL-27

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf
05/27/2011 SUPPL-25

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf
08/14/2009 SUPPL-24

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf
12/18/2007 SUPPL-22

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf
10/04/2005 SUPPL-20

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf
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