Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010104
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPHYTON | PHYTONADIONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/30/1955 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/010104Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/19/2021 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010104s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/010104Orig1s031ltr.pdf | |
| 03/16/2015 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/2010 | SUPPL-28 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010104s028ltr.pdf |
| 12/09/2004 | SUPPL-23 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf | |
| 02/09/2004 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10104slr022ltr.pdf |
| 06/04/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/24/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/19/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/13/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/08/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/07/1980 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/18/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/18/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/19/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010104s031lbl.pdf | |
| 12/09/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf |