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 | 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. |
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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. |
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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 |