Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063112
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 10MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1991 | 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 |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2012 | SUPPL-15 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf | |
| 04/07/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/07/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/27/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/16/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/10/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/02/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/12/2012 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf |