FDA — authorised 25 March 1976
- Application: NDA017657
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: CEPHULAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
🇺🇸 Cephulac in United States
FDA authorised Cephulac on 25 March 1976
Marketing authorisations
FDA — authorised 25 March 1976
- Status: approved
FDA — authorised 26 July 1988
- Application: ANDA071331
- Marketing authorisation holder: ALRA
- Local brand name: CHOLAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 26 July 1988
- Application: ANDA071054
- Marketing authorisation holder: ALRA
- Local brand name: CONSTILAC
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 August 1988
- Application: ANDA070288
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CONSTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 May 1992
- Application: ANDA073591
- Marketing authorisation holder: HIKMA
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 May 1992
- Application: ANDA073590
- Marketing authorisation holder: ROXANE
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 28 May 1993
- Application: ANDA073504
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: HEPTALAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 28 May 1993
- Application: ANDA073497
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: EVALOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 May 1993
- Application: ANDA073685
- Marketing authorisation holder: NOSTRUM LABS
- Local brand name: ACILAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 30 July 1996
- Application: ANDA074623
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 October 1996
- Application: ANDA074603
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GENERLAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 14 November 1996
- Application: ANDA074602
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 July 2001
- Application: ANDA075993
- Marketing authorisation holder: LANNETT CO INC
- Status: approved
FDA — authorised 21 November 2008
- Application: ANDA090426
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 25 January 2012
- Application: ANDA090503
- Marketing authorisation holder: FRESENIUS KABI
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 January 2012
- Application: ANDA090502
- Marketing authorisation holder: FRESENIUS KABI
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 27 March 2015
- Application: ANDA203762
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 11 June 2018
- Application: ANDA207786
- Marketing authorisation holder: APOZEAL PHARMS
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA209517
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 20 February 2024
- Application: ANDA076645
- Marketing authorisation holder: BAJAJ
- Indication: Labeling
- Status: approved
The FDA approved Cephulac, a drug product, for labeling indication on February 20, 2024. The marketing authorization holder is BAJAJ, and the application number is ANDA076645. This approval was granted under the standard expedited pathway.
FDA — authorised 13 December 2024
- Application: ANDA218858
- Marketing authorisation holder: TARO
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 14 March 2025
- Application: ANDA217914
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: LACTULOSE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA071842
- Marketing authorisation holder: MORTON GROVE
- Local brand name: GENERLAC
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA
- Application: ANDA071841
- Marketing authorisation holder: MORTON GROVE
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA072029
- Marketing authorisation holder: PACO
- Local brand name: LACTULOSE
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
Cephulac in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Cephulac approved in United States?
Yes. FDA authorised it on 25 March 1976; FDA authorised it on 25 March 1976; FDA authorised it on 26 July 1988.
Who is the marketing authorisation holder for Cephulac in United States?
SANOFI AVENTIS US holds the US marketing authorisation.