Documents
Application Sponsors
| NDA 050680 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | CREAM;VAGINAL | EQ 2% BASE | 0 | CLEOCIN | CLINDAMYCIN PHOSPHATE |
| 002 | CREAM;VAGINAL | EQ 2% BASE | 1 | CLEOCIN | CLINDAMYCIN PHOSPHATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-08-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1998-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2022-05-17 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
TE Codes
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 50680
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"CLEOCIN","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 2% BASE","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLEOCIN","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 2% BASE","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050680s018,050767s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050680s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050680s016,050767s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050680s013,050767s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050680s011,050767s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050680s010,050767s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050680s010,050767s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50680slr004_cleocin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLEOCIN","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 2% BASE","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLEOCIN","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 2% BASE","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-03-23
)
)