FDA.reportPublic FDA data

Application 050537

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCIN TCLINDAMYCIN PHOSPHATESOLUTION;TOPICALEQ 1% BASEYesYes
002CLEOCINCLINDAMYCIN PHOSPHATESWAB;TOPICALEQ 1% BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3116Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3116Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3116Cleocin Tclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-3116Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3116Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
59762-3728clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3728clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3728clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3728clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84160SUPPL 2025-11-13
84148SUPPL 2025-11-13
61335SUPPL2019-12-19
61319SUPPL2019-12-17
58704SUPPL2019-05-15
58387SUPPL2019-04-24
50451SUPPL2017-11-17
50439SUPPL2017-11-17
17860SUPPL2016-01-26
30061SUPPL2016-01-20
17859SUPPL2014-04-08
7796SUPPL2014-04-07
17858SUPPL2003-06-08
7795SUPPL2003-06-08
30060SUPPL2002-07-14
17857SUPPL2002-07-14