Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRIDOXINE HYDROCHLORIDE | PYRIDOXINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | 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 |
---|---|---|---|---|---|---|---|
08/14/1972 | 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 |
---|---|---|---|---|---|
09/22/2014 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
07/14/2005 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
11/25/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/18/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/07/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/10/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |