Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050609
Company: HOSPIRA

Products on NDA 050609

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROCIN	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
ERYTHROCIN	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050609

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/1986	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
11/18/2022	SUPPL-51	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050609Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050609Orig1s051ltr.pdf
11/05/2019	SUPPL-41	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050609s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050609Orig1s041ltr.pdf
04/23/2018	SUPPL-39	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050609s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050609Orig1s039ltr.pdf
10/27/2015	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
04/22/2015	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
08/19/2013	SUPPL-34	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/2013/050609s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050609Orig1s034ltr.pdf
02/02/2012	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050609s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050609s033ltr.pdf
06/09/2011	SUPPL-32	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050609s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050609s032ltr.pdf
02/26/2008	SUPPL-25	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050609s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050609s025ltr.pdf
09/16/2004	SUPPL-19	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50609s019,50182s125ltr.pdf
12/13/2002	SUPPL-18	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/29/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/2002	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf
11/08/1999	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/27/1997	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/18/1996	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/12/1993	SUPPL-9	Labeling		Label is not available on this site.
08/24/1994	SUPPL-8	Labeling		Label is not available on this site.
08/24/1994	SUPPL-7	Labeling		Label is not available on this site.
12/05/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/21/1987	SUPPL-2	Labeling		Label is not available on this site.

Labels for NDA 050609

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2022	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050609Orig1s051lbl.pdf
11/18/2022	SUPPL-51	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050609Orig1s051lbl.pdf
11/05/2019	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050609s041lbl.pdf
04/23/2018	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050609s039lbl.pdf
08/19/2013	SUPPL-34	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/2013/050609s034lbl.pdf
02/02/2012	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050609s033lbl.pdf
06/09/2011	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050609s032lbl.pdf
02/26/2008	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050609s025lbl.pdf

Therapeutic Equivalents for NDA 050609

ERYTHROCIN

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROCIN	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050609	HOSPIRA
ERYTHROCIN	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062638	HOSPIRA
ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215290	NEXUS