FDA.reportPublic FDA data

Application 011210

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESSALONBENZONATATECAPSULE;ORAL100MGYesNo
003TESSALONBENZONATATECAPSULE;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0122TessalonbenzonatatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0122TessalonbenzonatatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0122TessalonbenzonatatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0122TessalonbenzonatatePfizer Laboratories Div Pfizer IncNDACurrent
59762-1122BenzonatatebenzonatateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1122BenzonatatebenzonatateGreenstone LLCNDACurrent
59762-1122BenzonatatebenzonatateGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11924SUPPL2011-01-25
10757SUPPL2011-01-25