Drugs@FDA: FDA-Approved Drugs
Company: INTL MEDICATION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHYTONADIONE | PHYTONADIONE | 1MG/0.5ML | INJECTABLE;INJECTION | Prescription | BP | 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 |
---|---|---|---|---|---|---|---|
03/01/1976 | 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 |
---|---|---|---|---|---|
04/18/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
03/06/2002 | SUPPL-21 | Labeling |
Label is not available on this site. |
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01/04/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/19/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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11/10/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/17/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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01/14/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/29/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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08/30/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/1992 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s011.pdf |
08/05/1987 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s009.pdf |
07/11/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
PHYTONADIONE
There are no Therapeutic Equivalents.