FDA.report

Application 040275

Type
ANDA
Sponsor
EPIC PHARMA INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLTABLET;ORAL0.5MGNoNo
002ESTRADIOLESTRADIOLTABLET;ORAL1MGNoNo
003ESTRADIOLESTRADIOLTABLET;ORAL2MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0089ESTRADIOLESTRADIOLATLANTIC BIOLOGICALS CORP.ANDACurrent
23155-013EstradiolEstradiolHeritage Pharmaceuticals IncANDACurrent
23155-014EstradiolEstradiolHeritage Pharmaceuticals IncANDACurrent
23155-015EstradiolEstradiolHeritage Pharmaceuticals IncANDACurrent
24658-702ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLCANDACurrent
24658-703ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLCANDACurrent
24658-704ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLCANDACurrent
42806-087ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-087ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-087ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-088ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-088ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-088ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-089ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-089ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
42806-089ESTRADIOLESTRADIOLEPIC PHARMA, LLCANDACurrent
50090-5494ESTRADIOLESTRADIOLA-S Medication SolutionsANDACurrent
50090-5494ESTRADIOLESTRADIOLA-S Medication SolutionsANDACurrent
63629-4788ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
63629-4788ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
63629-8053ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
68071-3394ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3394ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3394ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4485ESTRADIOLESTRADIOLNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7102ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7102ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7102ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7102ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7102ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7332ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7332ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7332ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7332ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7567ESTRADIOLESTRADIOLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7567ESTRADIOLESTRADIOLPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2829ESTRADIOLESTRADIOLREMEDYREPACK INC.ANDACurrent
70518-2829ESTRADIOLESTRADIOLREMEDYREPACK INC.ANDACurrent
70934-798ESTRADIOLESTRADIOLDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0226ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
71335-0226ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
71335-0226ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
71335-0797ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
71335-0797ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
71335-0797ESTRADIOLESTRADIOLBryant Ranch PrepackANDACurrent
76420-021ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-021ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-021ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-021ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-022ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-022ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-022ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-022ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-023ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-023ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-023ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent
76420-023ESTRADIOLESTRADIOLAsclemed USA, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
38875ORIG2004-06-03
42608ORIG2003-07-31
29907ORIG1998-12-29