FDA.reportPublic FDA data

Application 017971

Type
NDA
Sponsor
JDS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESKALITHLITHIUM CARBONATETABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017971-001ESKALITHLITHIUM CARBONATE300MGTABLET / ORALApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N017971-001ESKALITH300MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017971-001ESKALITH300MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017971-001ESKALITH300MGTABLET / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LITHOBIDLITHIUM CARBONATEANI Pharmaceuticals, Inc.f7f5b69a-c2a1-4586-a189-1475d41387c02026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEHikma Pharmaceuticals USA Inc.b839ff4b-f62d-41ab-a823-550a756d58ec2026-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
lithium carbonateLITHIUM CARBONATECoupler LLC582697c1-063f-366f-e063-6294a90a8d1b2026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.803eab29-0d0a-4df0-b504-bcd85ec01ead2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.1c320bff-b4d5-42f2-b2b5-238564fe95892026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.05312159-3d8a-45e0-99cb-b83a7b200cd32026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.c84cce95-cfcb-4426-aac6-d2f48f946ada2026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.611b0ea2-6378-4c8f-953d-87f6b35b06342026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.aa900d48-a99f-4309-ba29-ecc8941627502026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.453721b5-b1f5-4161-8e01-8b4803151dc52026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.b074ca9f-66b2-4e83-b67d-cb317b46411b2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATECardinal Health 107, LLC0e6b0a2d-b79c-44d8-b785-5267df9e8f722026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEBryant Ranch Prepack1a62d5ae-a4a3-4b10-8281-feba134bbe3a2026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEAmerican Health Packaging049902a9-3af1-4863-994e-15f36e7a97932026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium Carbonate ERLITHIUM CARBONATECoupler LLC51b503f5-211f-a9cc-e063-6294a90a98952026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATECoupler LLC5102eb69-4872-53fb-e063-6394a90a82752026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
lithium carbonateLITHIUM CARBONATEREMEDYREPACK INC.01c4facd-ed79-4078-ba33-2044de372d0f2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.57faf0b0-4380-4bbf-8de7-c3f9d74fc4102026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium Carbonate ERLITHIUM CARBONATEREMEDYREPACK INC.bd4b07d3-ce42-440f-aec3-19f4d1c445a92026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.9cf3ceff-a237-44ea-b0dd-859e72c434d02026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LITHIUM CARBONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13973SUPPL2004-06-03
11106SUPPL2004-06-03