Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050775
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIAXIN XL | CLARITHROMYCIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/03/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50775lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50775ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50755_BiaxinXL.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2008 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 09/18/2019 | SUPPL-29 | 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-28 | 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-27 | 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-26 | 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-25 | 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-24 | 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-23 | 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 | |
| 05/26/2016 | SUPPL-22 | 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-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf | |
| 09/09/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf | |
| 05/03/2012 | SUPPL-19 | 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-18 | 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-17 | Labeling-Package Insert |
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-16 | 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-15 | 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 | |
| 05/27/2011 | SUPPL-14 | 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-13 | 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-12 | 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-11 | 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-9 | 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-8 | 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-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf |
| 12/20/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2003 | SUPPL-4 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50775slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-775s004_BiaxinXL.cfm |
| 11/16/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50775s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50775s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50775S1_Biaxin.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050662s061,050698s041,050775s029lbl.pdf | |
| 12/19/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s060,050698s040,050775s028lbl.pdf | |
| 11/25/2018 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s059,050698s039,050775s027lbl.pdf | |
| 06/09/2017 | SUPPL-26 | 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-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf | |
| 10/23/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf | |
| 01/08/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf | |
| 07/25/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf | |
| 09/09/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf | |
| 09/09/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf | |
| 07/05/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf | |
| 05/03/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf | |
| 05/03/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf | |
| 05/27/2011 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf | |
| 05/27/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf | |
| 08/14/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf | |
| 12/18/2007 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf | |
| 10/04/2005 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf | |
| 08/02/2001 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50775s1lbl.pdf | |
| 03/03/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50775lbl.pdf |