lithium citrate Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-03-10)
Oldest Current Product
1982-04-29
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\LITHIUM CITRATE
FDAOB
ORAL\SYRUP\LITHIUM CITRATE
SPL Active
ORAL\SOLUTION\LITHIUM CARBONATE
ORAL\SOLUTION\LITHIUM CITRATE
ORAL\SOLUTION\LITHIUM HYDROXIDE
SPL Moiety
ORAL\SOLUTION\LITHIUM CATION

product(s) by strength(s)

lithium citrate 60 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543527NDARoxane Laboratories, Inc1982-04-29LITHIUM CITRATEORALSOLUTIONNDA0184217dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1604320616ANDAMorton Grove Pharmaceuticals, Inc.1986-05-21LITHIUM HYDROXIDEORALSOLUTIONANDA0707557e7e3195-bf25-438c-a81f-136d3b528cb7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544952NDACardinal Health1982-04-29LITHIUM CARBONATEORALSOLUTION000548529NDA0184210e6b0a2d-b79c-44d8-b785-5267df9e8f72
2680940757NDAPrecision Dose Inc.2012-10-25LITHIUM CARBONATEORALSOLUTION000543527NDA0184211a04cc23-61fa-455b-9718-2cdcf54036e0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070755LITHIUM CITRATEWOCKHARDT EU OPERATIONS (SWISS) AG1986-05-21ANDA070755_001
2NDA017672LITHONATETrueSOLVAY PHARMACEUTICALSNDA017672_001
3NDA018421LITHIUM CITRATEROXANE LABORATORIES INCNDA018421_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070755_001RXLITHIUM CITRATE (EQ 300MG CARBONATE/5ML)ORALSYRUPFalseAA1986-05-21LITHIUM CITRATE
2NDA017672_001discontinuedLITHIUM CITRATE (EQ 300MG CARBONATE/5ML)ORALSYRUPFalseLITHONATE
3NDA018421_001RXLITHIUM CITRATE (EQ 300MG CARBONATE/5ML)ORALSYRUPTrueAALITHIUM CITRATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10e6b0a2d-b79c-44d8-b785-5267df9e8f72 (view SPL)LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-183551544952, 551544920, 551544941Lithium Carbonate Oral Capsule
Lithium Carbonate Oral Tablet
21a04cc23-61fa-455b-9718-2cdcf54036e0 (view SPL)LITHIUM Oral Solution USPprescriptionHuman PrescriptionPrecision Dose Inc.2013-12-262680940757
37dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e (view SPL)LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-03-1011000543527, 000542526, 000542527, 000542531, 000544527, 000548526, 000548527, 000548528, 000548529, 000548531Lithium Carbonate Oral Capsule
Lithium Carbonate Oral Tablet
47e7e3195-bf25-438c-a81f-136d3b528cb7 (view SPL)Lithium Oral Solution, USPprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2009-06-243604320616

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII