Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
11/18/2022 | SUPPL-51 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/18/2022 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050609Orig1s051lbl.pdf | |
11/18/2022 | SUPPL-51 | Labeling-Package Insert | 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 |
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 |