FDA Orange Book · active-ingredient family
Lithium carbonate
Lithium carbonate is approved as 10 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LITHIUM CARBONATE · NDA 017812
10
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LITHIUM CARBONATERLD×3 | HIKMA | NDA 017812 | AB | Jan 28, 1987 | |
| LITHIUM CARBONATERLD | HIKMA | NDA 018558 | AB | Jan 29, 1982 | |
| LITHOBIDRLD | ANI PHARMS | NDA 018027 | AB | Approved Prior to Jan 1, 1982 | |
| LITHANE | BAYER PHARMS | NDA 018833 | — | Jul 18, 1985 | |
| ESKALITH CR | JDS PHARMS | NDA 018152 | — | Mar 29, 1982 | |
| ESKALITH | NOVEN THERAP | NDA 016860 | — | Approved Prior to Jan 1, 1982 | |
| LITHONATE | SOLVAY | NDA 016782 | — | Approved Prior to Jan 1, 1982 | |
| ESKALITH | JDS PHARMS | NDA 017971 | — | Approved Prior to Jan 1, 1982 | |
| LITHIUM CARBONATE | PFIZER | NDA 016834 | — | Approved Prior to Jan 1, 1982 | |
| LITHOTABS | SOLVAY | NDA 016980 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LITHIUM CARBONATE | UNIQUE | ANDA 205663 | AB | Jun 05, 2017 | |
| LITHIUM CARBONATE | HERITAGE PHARMA | ANDA 205532 | AB | Sep 29, 2016 | |
| LITHIUM CARBONATE | UNIQUE | ANDA 204779 | AB | Jul 27, 2015 | |
| LITHIUM CARBONATE | ALEMBIC | ANDA 204445 | — | Jun 10, 2015 | |
| LITHIUM CARBONATE | PHARMOBEDIENT | ANDA 202219 | — | Aug 08, 2012 | |
| LITHIUM CARBONATE | PHARMOBEDIENT | ANDA 202288 | — | Jun 29, 2012 | |
| LITHIUM CARBONATE | GLENMARK PHARMS LTD | ANDA 091616 | AB | Feb 14, 2011 | |
| LITHIUM CARBONATE | HIKMA INTL PHARMS | ANDA 078715 | — | Dec 28, 2010 | |
| LITHIUM CARBONATE | GLENMARK PHARMS | ANDA 091544 | AB | Dec 27, 2010 | |
| LITHIUM CARBONATE | SUN PHARM INDS INC | ANDA 091027 | AB | Jun 24, 2010 | |
| LITHIUM CARBONATE×3 | HETERO LABS LTD III | ANDA 090702 | AB | Sep 25, 2009 | |
| LITHIUM CARBONATE×3 | GLENMARK PHARMS LTD | ANDA 079139 | AB | Feb 03, 2009 | |
| LITHIUM CARBONATE×3 | ALEMBIC LTD | ANDA 079159 | AB | Jan 12, 2009 | |
| LITHIUM CARBONATE | PHARMOBEDIENT | ANDA 078763 | — | Apr 15, 2008 | |
| LITHIUM CARBONATE | APOTEX INC | ANDA 076795 | — | Nov 22, 2004 | |
| LITHIUM CARBONATE | HIKMA | ANDA 076832 | AB | Oct 28, 2004 | |
| LITHIUM CARBONATE×3 | ABLE | ANDA 076823 | — | Jun 29, 2004 | |
| LITHIUM CARBONATE | HIKMA | ANDA 076691 | AB | Jan 05, 2004 | |
| LITHIUM CARBONATE | HERITAGE PHARMA | ANDA 076366 | — | Aug 21, 2003 | |
| LITHIUM CARBONATE | HIKMA INTL PHARMS | ANDA 076490 | — | Jun 17, 2003 | |
| LITHIUM CARBONATE | ABLE | ANDA 076382 | — | Apr 21, 2003 | |
| LITHIUM CARBONATE×2 | PHARMOBEDIENT | ANDA 076243 | — | Feb 24, 2003 | |
| LITHIUM CARBONATE | HERITAGE PHARMA | ANDA 076170 | — | Jun 10, 2002 | |
| LITHIUM CARBONATE | ABLE | ANDA 076121 | — | Sep 27, 2001 | |
| LITHIUM CARBONATE | USL PHARMA | ANDA 072542 | — | Feb 01, 1989 | |
| LITHIUM CARBONATE | WATSON LABS | ANDA 070407 | — | Mar 19, 1987 |
Listed patents
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.
Lithium carbonate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
