FDA.reportPublic FDA data

Application 050615

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCIN TCLINDAMYCIN PHOSPHATEGEL;TOPICALEQ 1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3331Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3331Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3331Cleocin Tclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-3331Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3331Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
59762-3743clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3743clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3743clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3743clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3743clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84162SUPPL 2025-11-13
84150SUPPL 2025-11-13
61336SUPPL2019-12-19
61321SUPPL2019-12-17
58706SUPPL2019-05-15
58389SUPPL2019-04-24
50453SUPPL2017-11-17
50441SUPPL2017-11-17
39042SUPPL2016-01-26
7889SUPPL2016-01-20
17932SUPPL2014-04-08
30173SUPPL2014-04-07
30172SUPPL2003-06-08
17931SUPPL2003-06-08
39041SUPPL2002-07-14
7888SUPPL2002-07-14