Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050662
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIAXIN | CLARITHROMYCIN | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| BIAXIN | CLARITHROMYCIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
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-61 | 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-60 | 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-59 | 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-58 | 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-57 | 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-56 | 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-55 | 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-54 | 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-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf | |
| 09/09/2013 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf | |
| 05/03/2012 | SUPPL-50 | 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 | |
| 11/23/2012 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/2012 | SUPPL-48 | 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-46 | 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-45 | 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-44 | 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-43 | 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-42 | 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-41 | 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-40 | 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-39 | 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-38 | 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-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf |
| 11/08/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/2002 | SUPPL-31 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm |
| 06/06/2002 | SUPPL-30 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm |
| 10/20/2000 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50662S29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50662S29ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S029_Biaxin.cfm | |
| 03/20/2000 | SUPPL-28 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S028_Biaxin.cfm |
| 05/04/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/27/1998 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/05/1998 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1998 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/16/1997 | SUPPL-19 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/16/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1997 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/20/1996 | SUPPL-13 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050662s013_biaxin.pdf |
| 08/26/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/31/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/15/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1995 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/28/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/28/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
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-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050662s061,050698s041,050775s029lbl.pdf | |
| 12/19/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s060,050698s040,050775s028lbl.pdf | |
| 11/25/2018 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050662s059,050698s039,050775s027lbl.pdf | |
| 06/09/2017 | SUPPL-58 | 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-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf | |
| 10/23/2015 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf | |
| 01/08/2015 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf | |
| 07/25/2014 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf | |
| 09/09/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s053lbl.pdf | |
| 09/09/2013 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s052lbl.pdf | |
| 07/05/2012 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf | |
| 05/03/2012 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf | |
| 05/03/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf | |
| 05/27/2011 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf | |
| 05/27/2011 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf | |
| 08/14/2009 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf | |
| 12/18/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf | |
| 10/04/2005 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf | |
| 10/20/2000 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50662S29lbl.pdf |