FDA.reportPublic FDA data

Application 208605

Type
ANDA
Sponsor
CADILA PHARMS LTD

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
71209-049TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-049TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-049TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-050TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-050TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-050TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-051TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-051TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
71209-051TelmisartanTelmisartanCadila Pharmaceuticals LimitedANDACurrent
72241-015TelmisartanTelmisartanModavar Pharmaceuticals LLCANDACurrent
72241-016TelmisartanTelmisartanModavar Pharmaceuticals LLCANDACurrent
72241-017TelmisartanTelmisartanModavar Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49119ORIG2017-07-28