FDA — authorised 11 April 1985
- Application: ANDA088894
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 BENZTROPINE MESYLATE in United States
FDA authorised BENZTROPINE MESYLATE on 11 April 1985 · 1,218 US adverse-event reports
Marketing authorisations
FDA — authorised 11 April 1985
- Application: ANDA088895
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 1985
- Application: ANDA088877
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 August 1988
- Application: ANDA089059
- Marketing authorisation holder: PLIVA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 August 1988
- Application: ANDA089060
- Marketing authorisation holder: PLIVA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 August 1988
- Application: ANDA089058
- Marketing authorisation holder: PLIVA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1989
- Application: ANDA072264
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1989
- Application: ANDA072266
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1989
- Application: ANDA072265
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1992
- Application: ANDA081265
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 1996
- Application: ANDA040103
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2007
- Application: ANDA040715
- Marketing authorisation holder: PH HEALTH
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2008
- Application: ANDA040706
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2009
- Application: ANDA090233
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BENZTROPINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2009
- Application: ANDA090287
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: BENZTROPINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2010
- Application: ANDA090294
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2010
- Application: ANDA091152
- Marketing authorisation holder: LUITPOLD
- Local brand name: BENZTROPINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 2012
- Application: ANDA090168
- Marketing authorisation holder: LEADING
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2013
- Application: ANDA091525
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: BENZTROPINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 April 2015
- Application: ANDA204713
- Marketing authorisation holder: NUVO PHARM
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 October 2021
- Application: ANDA209442
- Marketing authorisation holder: HIKMA
- Local brand name: BENZTROPINE MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA212694
- Marketing authorisation holder: QUAGEN
- Status: approved
FDA
- Application: ANDA089213
- Marketing authorisation holder: USL PHARMA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089212
- Marketing authorisation holder: USL PHARMA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089211
- Marketing authorisation holder: USL PHARMA
- Local brand name: BENZTROPINE MESYLATE
- Indication: TABLET — ORAL
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,218
Most-reported reactions
- Granulocytopenia — 152 reports (12.48%)
- Completed Suicide — 138 reports (11.33%)
- Tremor — 127 reports (10.43%)
- Death — 122 reports (10.02%)
- Diabetes Mellitus — 121 reports (9.93%)
- Drug Interaction — 120 reports (9.85%)
- Drug Ineffective — 117 reports (9.61%)
- Weight Increased — 115 reports (9.44%)
- Confusional State — 107 reports (8.78%)
- Constipation — 99 reports (8.13%)
BENZTROPINE MESYLATE 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 BENZTROPINE MESYLATE approved in United States?
Yes. FDA authorised it on 11 April 1985; FDA authorised it on 11 April 1985; FDA authorised it on 11 April 1985.
Who is the marketing authorisation holder for BENZTROPINE MESYLATE in United States?
LANNETT CO INC holds the US marketing authorisation.