FDA.reportPublic FDA data

Application 018027

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHOBIDLITHIUM CARBONATETABLET, EXTENDED RELEASE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-280LITHOBIDlithium carbonateANI Pharmaceuticals, Inc.NDACurrent
62559-280LITHOBIDlithium carbonateANI Pharmaceuticals, Inc.NDACurrent
62559-280LITHOBIDlithium carbonateANI Pharmaceuticals, Inc.NDACurrent
62559-280LITHOBIDlithium carbonateANI Pharmaceuticals, Inc.NDACurrent
62559-280LITHOBIDlithium carbonateANI Pharmaceuticals, Inc.NDACurrent
62559-340Lithium CarbonateLithium Carbonate Extended-Release TabletANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-340Lithium CarbonateLithium Carbonate Extended-Release TabletANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-340Lithium CarbonateLithium Carbonate Extended-Release TabletANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-340Lithium CarbonateLithium Carbonate Extended-Release TabletANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-340Lithium CarbonateLithium Carbonate Extended-Release TabletANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
63629-1955Lithium CarbonateLithium Carbonate Extended-Release TabletBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-1955Lithium CarbonateLithium Carbonate Extended-Release TabletBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-1955Lithium CarbonateLithium Carbonate Extended-Release TabletBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
70518-0629Lithium CarbonateLithium Carbonate Extended-Release TabletREMEDYREPACK INC.NDA AUTHORIZED Current
70518-0629Lithium CarbonateLithium Carbonate Extended-Release TabletREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71205-238Lithium CarbonateLithium Carbonate Extended-Release TabletProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-238Lithium CarbonateLithium Carbonate Extended-Release TabletProficient Rx LPNDA AUTHORIZED GENERICCurrent
71335-1543Lithium CarbonateLithium Carbonate Extended-ReleaseBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1543Lithium CarbonateLithium Carbonate Extended-ReleaseBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72381SUPPL2022-10-17
72324SUPPL2022-10-14
61858SUPPL2020-02-10
61790SUPPL2020-02-06
57001SUPPL2018-12-21
56954SUPPL2018-12-21
54010SUPPL2018-05-03
53996SUPPL2018-05-03
33397SUPPL2016-06-01
791SUPPL2016-06-01
11121SUPPL2011-10-25
790SUPPL2011-10-24
40773SUPPL2008-04-02
789SUPPL2006-10-05
788SUPPL2006-04-13
33396SUPPL2002-10-07
33395SUPPL2002-10-07
13984SUPPL2002-10-07
13983SUPPL2002-10-07
11120SUPPL2002-10-07
787SUPPL2002-10-07