FDA.reportPublic FDA data

Application 075502

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLECREAM;TOPICALEQ 0.05% BASE;1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0258Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0258Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0258Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
50436-4546Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateUnit Dose ServicesANDACurrent
55700-061Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateLake Erie Medical DBA Quality Care Products LLCANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-0339Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70786-0258Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateUnit Dose ServicesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30916ORIG2001-06-05
22479ORIG2001-06-05