FDA.reportPublic FDA data

Application 077152

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBUTALINE SULFATETERBUTALINE SULFATETABLET;ORAL2.5MGNoNo
002TERBUTALINE SULFATETERBUTALINE SULFATETABLET;ORAL5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1311Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1311Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1311Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1311Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1318Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1318Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1318Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
0527-1318Terbutaline SulfateTerbutaline SulfateLannett Company, Inc.ANDACurrent
10135-579Terbutaline SulfateTerbutaline SulfateMarlex Pharmaceuticals IncANDACurrent
10135-579Terbutaline SulfateTerbutaline SulfateMarlex Pharmaceuticals IncANDACurrent
10135-580Terbutaline SulfateTerbutaline SulfateMarlex Pharmaceuticals IncANDACurrent
10135-580Terbutaline SulfateTerbutaline SulfateMarlex Pharmaceuticals IncANDACurrent
21695-121Terbutaline SulfateTerbutaline SulfateRebel Distributors CorpANDACurrent
21695-122Terbutaline SulfateTerbutaline SulfateRebel Distributors CorpANDACurrent
43063-558Terbutaline SulfateTerbutaline SulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
53808-0312Terbutaline SulfateTERBUTALINE SULFATEState of Florida DOH Central PharmacyANDACurrent
67296-1053Terbutaline SulfateTerbutaline SulfateRedPharm Drug, Inc.ANDACurrent
67296-1053Terbutaline SulfateTerbutaline SulfateRedPharm Drug, Inc.ANDACurrent
67296-1053Terbutaline SulfateTerbutaline SulfateRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23860ORIG2011-02-17