Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050441
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/02/1972 | ORIG-1 | Approval | UNKNOWN |
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-86 | 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-85 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050441s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050441Orig1s085ltr.pdf | |
| 03/04/2020 | SUPPL-83 | 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-81 | 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-79 | 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-78 | 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/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf |
| 05/02/2017 | SUPPL-76 | 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/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf | |
| 08/05/2016 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/2016/050441s073,050639s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf | |
| 08/05/2016 | SUPPL-72 | 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 | |
| 03/24/2016 | SUPPL-71 | 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 | |
| 10/20/2014 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2014 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf | |
| 06/10/2014 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf | |
| 06/10/2014 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf | |
| 12/18/2012 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2011 | SUPPL-61 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf |
| 10/15/2010 | SUPPL-59 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050441s059ltr.pdf |
| 04/14/2008 | SUPPL-55 | 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-53 | 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/2008/050441s053ltr.pdf | |
| 01/28/2004 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf |
| 11/21/2001 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50441s47ltr.pdf | |
| 04/03/2000 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/2004 | SUPPL-45 | 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-44 | Labeling |
Label is not available on this site. |
||
| 07/17/1997 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/05/1996 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/23/1993 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-23 | Labeling |
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-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050441s085lbl.pdf | |
| 12/04/2021 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050441s086,050639s043lbl.pdf | |
| 03/04/2020 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050441s083,050639s041lbl.pdf | |
| 06/19/2019 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf | |
| 04/16/2018 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf | |
| 05/02/2017 | SUPPL-78 | 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-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf | |
| 08/05/2016 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/2016/050441s073,050639s034lbl.pdf | |
| 08/05/2016 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf | |
| 03/24/2016 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf | |
| 06/10/2014 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf | |
| 06/10/2014 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf | |
| 06/10/2014 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf | |
| 04/14/2008 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf | |
| 02/21/2008 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf | |
| 09/29/2004 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf | |
| 11/21/2001 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf |
CLEOCIN PHOSPHATE
INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050441 | PFIZER |
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062803 | PFIZER |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062800 | ALMAJECT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062943 | ALMAJECT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065346 | FRESENIUS KABI USA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065347 | FRESENIUS KABI USA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062889 | HIKMA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065206 | HIKMA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090108 | SAGENT PHARMS INC |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090109 | SAGENT PHARMS INC |