FDA.reportPublic FDA data

Application 078387

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL0.5MGNoNo
002ALPRAZOLAMALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL1MGNoNo
003ALPRAZOLAMALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL2MGNoNo
004ALPRAZOLAMALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-602AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
21695-603AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
21695-604AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
21695-605AlprazolamAlprazolamRebel Distributors Corp.ANDACurrent
33261-741AlprazolamAlprazolamAidarex Pharmaceuticals LLCANDACurrent
65162-809AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-809AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-809AlprazolamAlprazolamAmneal Pharmaceuticals, LLCANDACurrent
65162-809AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-809AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-810AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-810AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-810AlprazolamAlprazolamAmneal Pharmaceuticals, LLCANDACurrent
65162-810AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-810AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-812AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-812AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-812AlprazolamAlprazolamAmneal Pharmaceuticals, LLCANDACurrent
65162-812AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-812AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-813AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-813AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-813AlprazolamAlprazolamAmneal Pharmaceuticals, LLCANDACurrent
65162-813AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
65162-813AlprazolamAlprazolamAmneal Pharmaceuticals LLCANDACurrent
68788-9727AlprazolamAlprazolamPreferred Pharmaceuticals, Inc.ANDACurrent