Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYKROX | METOLAZONE | 0.5MG | TABLET;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
10/30/1987 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019532_Mycrox_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/19/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf |
10/29/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf |
04/17/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/15/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/2001 | SUPPL-12 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf | |
11/01/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/18/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/08/1999 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/16/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/31/1996 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/23/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
01/13/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/13/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
09/13/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/20/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/10/2001 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf |