FDA — authorised 6 April 1970
- Application: NDA016860
- Marketing authorisation holder: NOVEN THERAP
- Local brand name: ESKALITH
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Lithobid in United States
FDA authorised Lithobid on 6 April 1970
Marketing authorisations
FDA — authorised 26 February 1979
- Application: NDA017971
- Marketing authorisation holder: JDS PHARMS
- Local brand name: ESKALITH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 1979
- Application: NDA018027
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LITHOBID
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 1985
- Application: NDA018833
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: LITHANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2004
- Application: ANDA076691
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 3 February 2009
- Application: ANDA079139
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 25 September 2009
- Application: ANDA090702
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 24 June 2010
- Application: ANDA091027
- Marketing authorisation holder: SUN PHARM INDS INC
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA091616
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
Lithobid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Lithobid approved in United States?
Yes. FDA authorised it on 6 April 1970; FDA authorised it on 26 February 1979; FDA authorised it on 27 April 1979.
Who is the marketing authorisation holder for Lithobid in United States?
NOVEN THERAP holds the US marketing authorisation.