Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050537
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEOCIN | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Discontinued | None | Yes | No |
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/09/1980 | 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 |
|---|---|---|---|---|---|
| 12/16/2019 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050600Orig1s018,050615Orig1s019,050537Orig1s041ltr.pdf | |
| 04/19/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050537Orig1s040,050600Orig1s017,050615Orig1s018ltr.pdf | |
| 11/16/2017 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf | |
| 01/15/2016 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf | |
| 08/29/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf | |
| 05/30/2003 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf | |
| 06/07/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1981 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/25/1982 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/23/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/18/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/21/1992 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/2002 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf | |
| 07/28/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/20/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/11/1981 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/23/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/02/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/30/1980 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/16/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf | |
| 04/19/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf | |
| 11/16/2017 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf | |
| 01/15/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf | |
| 04/04/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf | |
| 05/30/2003 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf | |
| 07/14/2002 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf |