FDA.reportPublic FDA data

Application 050639

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 6MG BASE/MLYesYes
002CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 12MG BASE/MLYesYes
003CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 18MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3375Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3381Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3382Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3470Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-6780Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-9890Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85587SUPPL 2026-03-30
85564SUPPL 2026-03-30
85069SUPPL 2026-02-18
85040SUPPL 2026-02-13
71129SUPPL2022-05-23
71125SUPPL2022-05-23
69504SUPPL2021-12-07
69492SUPPL2021-12-07
62053SUPPL2020-03-05
62047SUPPL2020-03-05
59135SUPPL2019-06-20
59130SUPPL2019-06-20
53714SUPPL2018-04-17
53702SUPPL2018-04-17
48282SUPPL2017-05-08
48281SUPPL2017-05-08
48255SUPPL2017-05-05
48254SUPPL2017-05-05
45030SUPPL2016-08-05
45029SUPPL2016-08-05
45006SUPPL2016-08-05
45005SUPPL2016-08-05
39065SUPPL2016-03-29
30210SUPPL2016-03-28
39064SUPPL2014-07-03
17963SUPPL2014-07-03
17962SUPPL2014-07-03
30209SUPPL2014-06-27
7919SUPPL2014-06-27
7918SUPPL2014-06-27
7917SUPPL2011-06-10
17961SUPPL2008-04-23
7916SUPPL2008-04-16
30208SUPPL2008-02-25
17960SUPPL2008-02-25
39063SUPPL2004-10-04
7915SUPPL2004-10-04
30207SUPPL2004-02-02