Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050680
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLEOCIN | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | Discontinued | None | No | No |
CLEOCIN | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/11/1992 | 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 |
---|---|---|---|---|---|
05/17/2022 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050680s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050680Orig1s019ltr.pdf | |
03/23/2020 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050680s018,050767s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050680Orig1s018, 050767Orig1s017ltr.pdf | |
05/21/2019 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050680s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050680Orig1s017ltr.pdf | |
12/20/2018 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf | |
09/08/2017 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050680Orig1s013,050767Orig1s014ltr.pdf | |
07/13/2015 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf | |
05/09/2014 | SUPPL-10 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf | |
08/20/2003 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50680slr004ltr.pdf | |
08/05/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/02/1998 | SUPPL-2 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680s002_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680S002.cfm |
10/05/1995 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/17/2022 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050680s019lbl.pdf | |
03/23/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050680s018,050767s017lbl.pdf | |
05/21/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050680s017lbl.pdf | |
12/20/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf | |
09/08/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf | |
07/13/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf | |
05/09/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf | |
05/09/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf | |
08/20/2003 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf |
CLEOCIN
CREAM;VAGINAL; EQ 2% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLEOCIN | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | Prescription | Yes | AB | 050680 | PFIZER |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | Prescription | No | AB | 065139 | FOUGERA PHARMS |