FDA.reportPublic FDA data

Application 050600

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3329Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3329Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3329Cleocin Tclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-3329Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3329Cleocin Tclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
59762-3744clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3744clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3744clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3744clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3744clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84161SUPPL 2025-11-13
84149SUPPL 2025-11-13
61337SUPPL2019-12-19
61320SUPPL2019-12-17
58705SUPPL2019-05-15
58388SUPPL2019-04-24
50452SUPPL2017-11-17
50440SUPPL2017-11-17
39030SUPPL2016-01-26
7873SUPPL2016-01-20
39029SUPPL2014-04-08
7872SUPPL2014-04-07
39028SUPPL2003-06-08
7871SUPPL2003-06-08
30149SUPPL2002-07-14
17917SUPPL2002-07-14