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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062638
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 No No
ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No 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
10/31/1986 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2021 SUPPL-40 Labeling-Package Insert

Label is not available on this site.
07/16/2021 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
09/21/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.
09/21/2015 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/26/2013 SUPPL-29 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062638s029lbl.pdf
07/21/2004 SUPPL-20 Labeling

Label is not available on this site.
09/11/2002 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/09/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/16/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
05/22/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
05/22/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
05/10/1995 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/10/1996 SUPPL-12 Labeling

Label is not available on this site.
10/14/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
10/30/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
04/28/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
05/10/1996 SUPPL-8 Labeling

Label is not available on this site.
05/10/1996 SUPPL-7 Labeling

Label is not available on this site.
05/10/1996 SUPPL-6 Labeling

Label is not available on this site.
09/26/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/30/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/26/2013 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/062638s029lbl.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 215290 NEXUS
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