FDA.reportPublic FDA data

Application 211158

Type
NDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIGECYCLINETIGECYCLINEPOWDER;INTRAVENOUS50MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1647TigecyclineTigecyclineAmneal Biosciences LLCNDACurrent
70121-1647TigecyclineTigecyclineAmneal Pharmaceuticals LLCNDACurrent
70121-1647TigecyclineTigecyclineAmneal Pharmaceuticals LLCNDACurrent
70121-1647TigecyclineTigecyclineAmneal Pharmaceuticals LLCNDACurrent
70121-1647TigecyclineTigecyclineAmneal Pharmaceuticals LLCNDACurrent
70121-1647TigecyclineTigecyclineAmneal Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81865SUPPL 2025-04-08
81797SUPPL 2025-04-02
67485SUPPL2021-05-13
65203SUPPL2020-11-13
65200SUPPL2020-11-12
64190SUPPL2020-08-03
64177SUPPL2020-08-03
56327ORIG2018-11-07
55100ORIG2018-08-03
55080ORIG2018-08-03