FDA.reportPublic FDA data

Application 064160

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0202clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0202clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0202clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0202clindamycin phosphateclindamycin phosphateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
50090-0768clindamycin phosphateclindamycin phosphateA-S Medication SolutionsANDACurrent
50090-0768clindamycin phosphateclindamycin phosphateA-S Medication SolutionsANDACurrent
50090-0768clindamycin phosphateclindamycin phosphateA-S Medication SolutionsANDACurrent
68788-9780clindamycin phosphateclindamycin phosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9780clindamycin phosphateclindamycin phosphatePreferred Pharmaceuticals, Inc.ANDACurrent
70859-050NuCaraRXPAKClindamycin Phosphate,Benzoyl Peroxide,CetaphilNuCare Pharmaceuticals,Inc.ANDACurrent
70859-050NuCaraRXPAKClindamycin Phosphate,Benzoyl Peroxide,CetaphilNuCare Pharmaceuticals,Inc.ANDACurrent
70859-051NuCaraClinPAKClindamycin Phosphate,CetaphilNuCare Pharmaceuticals,Inc.ANDACurrent
70859-051NuCaraClinPAKClindamycin Phosphate,CetaphilNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42787ORIG2003-08-27
30619ORIG2000-01-28