FDA — authorised 21 December 1993
- Application: ANDA073654
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Beta-blockers in United States
FDA authorised Beta-blockers on 21 December 1993 · 136 US adverse-event reports
Marketing authorisations
FDA — authorised 21 December 1993
- Application: ANDA074032
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 1993
- Application: ANDA073666
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA074333
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA074258
- Marketing authorisation holder: APOTHECON
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1994
- Application: ANDA073288
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1994
- Application: ANDA073289
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 1994
- Application: ANDA074217
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 1995
- Application: ANDA074453
- Marketing authorisation holder: RENATA
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1996
- Application: ANDA074644
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 1998
- Application: ANDA075160
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 July 2003
- Application: ANDA076495
- Marketing authorisation holder: HIKMA
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 2004
- Application: ANDA076670
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2007
- Application: ANDA077761
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 September 2007
- Application: ANDA077739
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2007
- Application: ANDA077360
- Marketing authorisation holder: SANDOZ
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2008
- Application: ANDA078085
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 June 2008
- Application: ANDA078459
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2010
- Application: ANDA090317
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 2010
- Application: ANDA091307
- Marketing authorisation holder: LUITPOLD
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2013
- Application: ANDA078950
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2013
- Application: ANDA202871
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2014
- Application: ANDA204205
- Marketing authorisation holder: GLAND
- Local brand name: METOPROLOL TARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 October 2014
- Application: ANDA200981
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2020
- Application: ANDA208955
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA212402
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA074380
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METOPROLOL TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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: 136
Most-reported reactions
- Myocardial Infarction — 17 reports (12.5%)
- Death — 16 reports (11.76%)
- Hypotension — 16 reports (11.76%)
- Dyspnoea — 13 reports (9.56%)
- Fatigue — 13 reports (9.56%)
- Nausea — 13 reports (9.56%)
- Ventricular Arrhythmia — 13 reports (9.56%)
- Drug Ineffective — 12 reports (8.82%)
- Thrombosis In Device — 12 reports (8.82%)
- Asthenia — 11 reports (8.09%)
Beta-blockers 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 Beta-blockers approved in United States?
Yes. FDA authorised it on 21 December 1993; FDA authorised it on 21 December 1993; FDA authorised it on 21 December 1993.
Who is the marketing authorisation holder for Beta-blockers in United States?
SUN PHARM INDUSTRIES holds the US marketing authorisation.