Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064210
Company: XGEN PHARMS
Company: XGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STREPTOMYCIN SULFATE | STREPTOMYCIN SULFATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64210ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2012 | SUPPL-9 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf | |
07/23/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/23/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/30/2012 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064210s009lbl.pdf |