FDA.reportPublic FDA data

Application 050680

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCINCLINDAMYCIN PHOSPHATECREAM;VAGINALEQ 2% BASENoNo
002CLEOCINCLINDAMYCIN PHOSPHATECREAM;VAGINALEQ 2% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3448Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia & Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
0009-3448Cleocinclindamycin phosphatePharmacia and Upjohn Company LLCNDACurrent
59762-5009clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5009clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5009clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5009clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5009clindamycin phosphateclindamycin phosphateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71099SUPPL2022-05-19
71090SUPPL2022-05-18
62300SUPPL2020-03-24
62297SUPPL2020-03-24
58832SUPPL2019-05-22
58826SUPPL2019-05-22
56974SUPPL2018-12-21
49747SUPPL2017-09-15
49706SUPPL2017-09-11
18008SUPPL2015-07-16
7986SUPPL2015-07-15
39103SUPPL2014-05-12
30265SUPPL2014-05-12
18007SUPPL2003-08-29
7985SUPPL2003-08-29
22182SUPPL1998-03-02
7984SUPPL1998-03-02