Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050639
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/30/1989 | 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 |
|---|---|---|---|---|---|
| 12/04/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050441s086,050639s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050441Orig1s086; 050639Orig1s043ltr.pdf | |
| 05/20/2022 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050639s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050639Orig1s042ltr.pdf | |
| 03/04/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050441s083,050639s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050441Orig1s083, 050639Orig1s041ltr.pdf | |
| 06/19/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050441Orig1s081, 050639Orig1s040ltr.pdf | |
| 04/16/2018 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050441Orig1s079,050639Orig1s038ltr.pdf | |
| 05/02/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf |
| 05/02/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf | |
| 08/05/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf | |
| 08/05/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf | |
| 05/20/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf | |
| 09/18/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf | |
| 06/25/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf | |
| 06/25/2014 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf | |
| 10/09/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2011 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf |
| 04/14/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf | |
| 02/21/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050639s015ltr.pdf | |
| 01/28/2004 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf |
| 09/29/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf | |
| 12/12/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/21/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/18/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/20/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050639s042lbl.pdf | |
| 12/04/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050441s086,050639s043lbl.pdf | |
| 03/04/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050441s083,050639s041lbl.pdf | |
| 06/19/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf | |
| 04/16/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf | |
| 05/02/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf |
| 05/02/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf | |
| 08/05/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf | |
| 08/05/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf | |
| 03/24/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf | |
| 06/25/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf | |
| 06/25/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf | |
| 06/25/2014 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf | |
| 04/14/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf | |
| 02/21/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf | |
| 09/29/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf |