Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018045
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMCYT | ESTRAMUSTINE PHOSPHATE SODIUM | EQ 140MG PHOSPHATE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/14/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018045s023ltr.pdf | |
| 10/28/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18045slr021ltr.pdf | |
| 09/07/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18045s16ltr.pdf |
| 01/11/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/25/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 07/09/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf | |
| 10/28/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf |