🇺🇸 Treatment in United States

FDA authorised Treatment on 17 November 2000 · 305,699 US adverse-event reports

Marketing authorisations

FDA — authorised 17 November 2000

  • Application: ANDA075518
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 9 November 2007

  • Application: ANDA078176
  • Marketing authorisation holder: PURE SOURCE
  • Status: approved

FDA — authorised 2 June 2010

  • Application: ANDA090962
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 28 April 2011

  • Application: ANDA091344
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: approved

FDA — authorised 4 December 2019

  • Application: ANDA209074
  • Marketing authorisation holder: TARO
  • Indication: Labeling
  • Status: approved

Read official source →

FDA — authorised 14 January 2022

  • Application: ANDA215940
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 50,576 reports (16.54%)
  2. Dry Skin — 44,567 reports (14.58%)
  3. Skin Burning Sensation — 41,393 reports (13.54%)
  4. Acne — 38,919 reports (12.73%)
  5. Erythema — 38,307 reports (12.53%)
  6. Skin Irritation — 25,981 reports (8.5%)
  7. Skin Exfoliation — 21,099 reports (6.9%)
  8. Inappropriate Schedule Of Product Administration — 16,150 reports (5.28%)
  9. Rash — 15,486 reports (5.07%)
  10. Overdose — 13,221 reports (4.32%)

Source database →

Treatment in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Treatment approved in United States?

Yes. FDA authorised it on 17 November 2000; FDA authorised it on 9 November 2007; FDA authorised it on 2 June 2010.

Who is the marketing authorisation holder for Treatment in United States?

P AND L holds the US marketing authorisation.