FDA.reportPublic FDA data

Application 050767

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCINCLINDAMYCIN PHOSPHATESUPPOSITORY;VAGINAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-7667Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-7667Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-7667Cleocinclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-7667Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-7667Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-7667Cleocinclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
63539-011Cleocinclindamycin phosphateU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71729SUPPL2022-08-05
71638SUPPL2022-07-27
71100SUPPL2022-05-19
71091SUPPL2022-05-18
62301SUPPL2020-03-24
62298SUPPL2020-03-24
60028SUPPL2019-09-18
60025SUPPL2019-09-17
56975SUPPL2018-12-21
49748SUPPL2017-09-15
49707SUPPL2017-09-11
39303SUPPL2015-07-16
8245SUPPL2015-07-15
18215SUPPL2014-05-12
8244SUPPL2014-05-12
18214SUPPL2013-06-26
30504SUPPL2013-06-20
42730ORIG1999-08-13
30503ORIG1999-08-13
18213ORIG1999-08-13