Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063116
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
05/18/1992 | 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 |
---|---|---|---|---|---|
12/08/2011 | SUPPL-10 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf | |
10/04/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/25/2002 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
02/16/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1996 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/02/1994 | 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 |
---|---|---|---|---|---|
12/08/2011 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf |