FDA.reportPublic FDA data

Application 209167

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
50090-6150TadalafilTadalafilA-S Medication SolutionsANDACurrent
50436-0370TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-0370TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-0372TadalafilTadalafilUnit Dose ServicesANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
68071-2553TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5186TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5186TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5202TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5202TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5272TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5272TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8153TadalafilTadalafilPreferred Pharmaceuticals Inc.ANDACurrent
70518-2972TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70518-2972TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70934-795TadalafilTadalafilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-720TadalafilTadalafilProficient Rx LPANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1620TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1620TadalafilTadalafilBryant Ranch PrepackANDACurrent
71455-597TADALAFILTADALAFILUNYTER ENTERPRISESANDACurrent
76420-126TadalafilTadalafilAsclemed USA, Inc.ANDACurrent
76420-126TadalafilTadalafilAsclemed USA, Inc.ANDACurrent