Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050609
Company: HOSPIRA
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
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
11/05/2019 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 211086 EXELA PHARMA

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