Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080618
Company: FRESENIUS KABI USA
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. |
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| 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. |
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| 07/22/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |