FDA.reportPublic FDA data

Application 200739

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.25MGNoNo
002ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.5MGNoNo
003ALPRAZOLAMALPRAZOLAMTABLET;ORAL1MGNoNo
004ALPRAZOLAMALPRAZOLAMTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53002-3950AlprazolamAlprazolamRPK Pharmaceuticals, Inc.ANDACurrent
53002-3950AlprazolamAlprazolamRPK Pharmaceuticals, Inc.ANDACurrent
55700-491AlprazolamAlprazolamLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-456ALPRAZOLAMALPRAZOLAMDirect RxANDACurrent
61919-456ALPRAZOLAMALPRAZOLAMDirect RxANDACurrent
63187-966AlprazolamAlprazolamProficient Rx LPANDACurrent
63187-966AlprazolamAlprazolamProficient Rx LPANDACurrent
66267-820AlprazolamAlprazolamNuCare Pharmaceuticals,Inc.ANDACurrent
66267-820AlprazolamAlprazolamNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1379AlprazolamAlprazolamRedPharm Drug, Inc.ANDACurrent
67296-1379AlprazolamAlprazolamRedPharm Drug, Inc.ANDACurrent
68071-1884AlprazolamAlprazolamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1888AlprazolamAlprazolamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1966AlprazolamAlprazolamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3049AlprazolamAlprazolamNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6865AlprazolamAlprazolamPreferred Pharmaceuticals Inc.ANDACurrent
69452-110AlprazolamAlprazolamBionpharma Inc.ANDACurrent
69452-111AlprazolamAlprazolamBionpharma Inc.ANDACurrent
69452-112AlprazolamAlprazolamBionpharma Inc.ANDACurrent
69452-113AlprazolamAlprazolamBionpharma Inc.ANDACurrent
71335-0163AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0215AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0247AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0448AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
71335-0850AlprazolamAlprazolamBryant Ranch PrepackANDACurrent