FDA Orange Book · active-ingredient family
Lithium carbonate
Lithium carbonate: 10 brands, 26 generics; first approved Jan 29, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
10
Generics (ANDA)
26
Listed patents
0
Presentations
47
Brand (NDA) products
Originator applications
- LITHIUM CARBONATERLDHIKMANDA 01781219873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 600MG CAPSULE ORAL Rx AB - LITHIUM CARBONATERLDRSHIKMANDA 0185581982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx — - ANI PHARMSNDA 018027—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB - BAYER PHARMSNDA 0188331985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - JDS PHARMSNDA 0181521982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Discontinued — - NOVEN THERAPNDA 016860—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - SOLVAYNDA 016782—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - JDS PHARMSNDA 017971—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - LITHIUM CARBONATEPFIZERNDA 016834—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - SOLVAYNDA 016980—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- LITHIUM CARBONATEUNIQUEANDA 2056632017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEHERITAGE PHARMAANDA 2055322016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEUNIQUEANDA 2047792015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEALEMBICANDA 2044452015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEPHARMOBEDIENTANDA 2022192012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEPHARMOBEDIENTANDA 2022882012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEGLENMARK PHARMS LTDANDA 0916162011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEHIKMA INTL PHARMSANDA 0787152010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - LITHIUM CARBONATEGLENMARK PHARMSANDA 0915442010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATESUN PHARM INDS INCANDA 0910272010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - LITHIUM CARBONATEHETERO LABS LTD IIIANDA 09070220093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 600MG CAPSULE ORAL Rx AB - LITHIUM CARBONATEGLENMARK PHARMS LTDANDA 07913920093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 600MG CAPSULE ORAL Rx AB - LITHIUM CARBONATEALEMBIC LTDANDA 07915920093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 600MG CAPSULE ORAL Rx AB - LITHIUM CARBONATEPHARMOBEDIENTANDA 0787632008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATEAPOTEX INCANDA 0767952004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATEHIKMAANDA 0768322004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEABLEANDA 07682320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 600MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATERSHIKMAANDA 0766912004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Rx AB - LITHIUM CARBONATEHERITAGE PHARMAANDA 0763662003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEHIKMA INTL PHARMSANDA 0764902003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEABLEANDA 0763822003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEPHARMOBEDIENTANDA 07624320032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATEHERITAGE PHARMAANDA 0761702002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LITHIUM CARBONATEABLEANDA 0761212001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATEUSL PHARMAANDA 0725421989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - LITHIUM CARBONATEWATSON LABSANDA 0704071987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 4 mo ago
Most recent approval
9 yr 6 mo ago
Approvals span 1982–2017 across 36 FDA applications.
Brand (NDA) 1028%
Generic (ANDA) 2672%
Lithium carbonate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
