FDA.reportPublic FDA data

Application 204415

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTANTELMISARTANTABLET;ORAL20MGNoNo
002TELMISARTANTELMISARTANTABLET;ORAL40MGNoNo
003TELMISARTANTELMISARTANTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-790TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-790TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-790TelmisartanTelmisartanAvKAREANDACurrent
42291-790TelmisartanTelmisartanAvKAREANDACurrent
42291-791TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-791TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-791TelmisartanTelmisartanAvKAREANDACurrent
42291-791TelmisartanTelmisartanAvKAREANDACurrent
42291-792TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-792TelmisartanTelmisartanAvKARE, Inc.ANDACurrent
42291-792TelmisartanTelmisartanAvKAREANDACurrent
42291-792TelmisartanTelmisartanAvKAREANDACurrent
53746-291TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-291TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-291TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-292TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-292TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-292TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-293TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-293TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
53746-293TelmisartanTelmisartanAmneal Pharmaceuticals of New York LLCANDACurrent
65162-291TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-291TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-291TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-291TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-292TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-292TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-292TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-292TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-293TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-293TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-293TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent
65162-293TelmisartanTelmisartanAmneal Pharmaceuticals LLCANDACurrent