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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050698
Company: ABBVIE

Other Important Information from FDA

Products on NDA 50698

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

Labels for NDA 050698

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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