Drugs@FDA: FDA-Approved Drugs
Company: RECORDATI RARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MUSTARGEN | MECHLORETHAMINE HYDROCHLORIDE | 10MG/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
03/15/1949 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/09/2004 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06695slr031ltr.pdf | |
03/19/2003 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06695slr030ltr.pdf |
11/17/2000 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/15/2000 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
10/16/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/16/1998 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/13/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/10/1995 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/22/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/20/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/12/1995 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/18/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
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01/15/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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03/29/1986 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
02/21/1983 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/04/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/19/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/12/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/09/2004 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf |