FDA.reportPublic FDA data

Application 076468

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANAGRELIDE HYDROCHLORIDEANAGRELIDE HYDROCHLORIDECAPSULE;ORALEQ 0.5MG BASENoNo
002ANAGRELIDE HYDROCHLORIDEANAGRELIDE HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5240Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5241Anagrelide HydrochlorideAnagrelide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
68151-2959Anagrelide HydrochlorideAnagrelide HydrochlorideCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31125ORIG2005-04-28