Drugs@FDA: FDA-Approved Drugs
Company: BAYER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCELEX | CLOTRIMAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TROCHE/LOZENGE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/17/1983 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
12/15/2002 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18713slr019ltr.pdf | |
03/26/2001 | SUPPL-17 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018713_S017_MYCELEX TROCHE_AP.pdf |
01/23/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/07/1999 | SUPPL-14 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018713_S014_MYCELEX TROCHE_AP.pdf |
06/30/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/30/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
01/18/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/15/1989 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/07/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/29/1992 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
01/15/1988 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/27/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/03/1987 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018713_S004_MYCELEX TROCHE_AP.pdf |
09/11/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/13/1984 | 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 |
---|---|---|---|---|---|
12/15/2002 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf |