FDA — authorised 6 April 1970
- Application: NDA016834
- Marketing authorisation holder: PFIZER
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Theralite® in United States
FDA authorised Theralite® on 6 April 1970
Marketing authorisations
FDA — authorised 6 April 1970
- Application: NDA016782
- Marketing authorisation holder: SOLVAY
- Local brand name: LITHONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1972
- Application: NDA016980
- Marketing authorisation holder: SOLVAY
- Local brand name: LITHOTABS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1980
- Application: NDA017812
- Marketing authorisation holder: HIKMA
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 1982
- Application: NDA018558
- Marketing authorisation holder: HIKMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 1982
- Application: NDA018152
- Marketing authorisation holder: JDS PHARMS
- Local brand name: ESKALITH CR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 September 2001
- Application: ANDA076121
- Marketing authorisation holder: ABLE
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 June 2002
- Application: ANDA076170
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 June 2002
- Application: ANDA076243
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 2003
- Application: ANDA076382
- Marketing authorisation holder: ABLE
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 June 2003
- Application: ANDA076490
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 August 2003
- Application: ANDA076366
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 January 2004
- Application: ANDA076691
- Marketing authorisation holder: HIKMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2004
- Application: ANDA076823
- Marketing authorisation holder: ABLE
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 2004
- Application: ANDA076832
- Marketing authorisation holder: HIKMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 November 2004
- Application: ANDA076795
- Marketing authorisation holder: APOTEX INC
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 January 2009
- Application: ANDA079159
- Marketing authorisation holder: ALEMBIC LTD
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 February 2009
- Application: ANDA079139
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 2009
- Application: ANDA090702
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 2010
- Application: ANDA091027
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2010
- Application: ANDA091544
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 December 2010
- Application: ANDA078715
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2011
- Application: ANDA091616
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2012
- Application: ANDA202288
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 August 2012
- Application: ANDA202219
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 June 2015
- Application: ANDA204445
- Marketing authorisation holder: ALEMBIC
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 July 2015
- Application: ANDA204779
- Marketing authorisation holder: UNIQUE
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 September 2016
- Application: ANDA205532
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA205663
- Marketing authorisation holder: UNIQUE
- Local brand name: LITHIUM CARBONATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA070407
- Marketing authorisation holder: WATSON LABS
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072542
- Marketing authorisation holder: USL PHARMA
- Local brand name: LITHIUM CARBONATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Theralite® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Theralite® approved in United States?
Yes. FDA authorised it on 6 April 1970; FDA authorised it on 6 April 1970; FDA authorised it on 24 April 1972.
Who is the marketing authorisation holder for Theralite® in United States?
PFIZER holds the US marketing authorisation.