FDA.report

Application 072711

Type
ANDA
Sponsor
EPIC PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SULINDACSULINDACTABLET;ORAL200MGNoNo
002SULINDACSULINDACTABLET;ORAL150MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6216SulindacSulindacMajor PharmaceuticalsANDACurrent
0904-6216SulindacSulindacMajor PharmaceuticalsANDACurrent
0904-6217SulindacSulindacMajor PharmaceuticalsANDACurrent
0904-6217SulindacSulindacMajor PharmaceuticalsANDACurrent
24658-771SULINDACSULINDACPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-771SULINDACSULINDACPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-771SULINDACSULINDACPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
33261-100SulindacSulindacAidarex Pharmaceuticals LLCANDACurrent
42806-011SULINDACSULINDACEpic Pharma, LLCANDACurrent
42806-011SULINDACSULINDACEpic Pharma, LLCANDACurrent
50090-0529SULINDACSULINDACA-S Medication SolutionsANDACurrent
50090-4976SulindacSulindacA-S Medication SolutionsANDACurrent
50090-4976SulindacSulindacA-S Medication SolutionsANDACurrent
50090-4976SulindacSulindacA-S Medication SolutionsANDACurrent
53808-0814SulindacSulindacState of Florida DOH Central PharmacyANDACurrent
55700-682SULINDACSULINDACLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-682SULINDACSULINDACLake Erie Medical DBA Quality Care Products LLCANDACurrent
71205-648SULINDACSULINDACProficient Rx LPANDACurrent
71335-0535SULINDACSULINDACBryant Ranch PrepackANDACurrent
71335-0535SULINDACSULINDACBryant Ranch PrepackANDACurrent