FDA.reportPublic FDA data

Application 021302

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELIDELPIMECROLIMUSCREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5100ELIDELPimecrolimusValeant Pharmaceuticals North America LLCNDACurrent
0187-5100ELIDELPimecrolimusBausch Health US LLCNDACurrent
0187-5100ELIDELPimecrolimusBausch Health US, LLCNDACurrent
0187-5101ELIDELPimecrolimusBausch Health US, LLCNDACurrent
0187-5101ELIDELPimecrolimusValeant Pharmaceuticals North America LLCNDACurrent
0187-5101ELIDELPimecrolimusBausch Health US LLCNDACurrent
0187-5102ELIDELPimecrolimusBausch Health US, LLCNDACurrent
0187-5102ELIDELPimecrolimusValeant Pharmaceuticals North America LLCNDACurrent
0187-5102ELIDELPimecrolimusBausch Health US LLCNDACurrent
0187-5103ELIDELPimecrolimusValeant Pharmaceuticals North America LLCNDACurrent
0187-5103ELIDELPimecrolimusBausch Health US LLCNDACurrent
0187-5103ELIDELPimecrolimusBausch Health US, LLCNDACurrent
68682-110PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-110PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-110PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-111PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-111PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-111PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-112PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-112PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-112PimecrolimusPimecrolimusOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
4968SUPPL2014-04-02
15138SUPPL2014-04-01
43739ORIG2011-01-13
27419SUPPL2010-07-23
36614SUPPL2010-07-22
15137SUPPL2007-08-14
4967SUPPL2007-08-14
4966SUPPL2006-01-30
36613SUPPL2006-01-19
15136SUPPL2004-12-03
27418SUPPL2004-12-02
36612SUPPL2003-10-17
27417SUPPL2003-10-17
42090ORIG2001-12-13
36611ORIG2001-12-13
4965ORIG2001-12-13