FDA.reportPublic FDA data

Application 065067

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATELOTION;TOPICALEQ 1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0203clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0203clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0203clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0203clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
68071-5099clindamycin phosphateclindamycin phosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5099clindamycin phosphateclindamycin phosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7040clindamycin phosphateclindamycin phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7040clindamycin phosphateclindamycin phosphatePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42806ORIG2005-07-22