FDA — authorised 12 November 1985
- Application: ANDA070617
- Marketing authorisation holder: LUITPOLD
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Verapamil Hydrochloride in United States
FDA authorised Verapamil Hydrochloride on 12 November 1985 · 3,278 US adverse-event reports
Marketing authorisations
FDA — authorised 16 December 1985
- Application: ANDA070451
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 August 1986
- Application: ANDA070340
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 1986
- Application: ANDA070341
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 1986
- Application: ANDA071019
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 1986
- Application: ANDA070468
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA070994
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA071367
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA070995
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA071366
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA070738
- Marketing authorisation holder: HOSPIRA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA070740
- Marketing authorisation holder: HOSPIRA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA070739
- Marketing authorisation holder: HOSPIRA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 1987
- Application: ANDA070737
- Marketing authorisation holder: HOSPIRA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 1988
- Application: ANDA071424
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 May 1988
- Application: ANDA071423
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1989
- Application: ANDA072125
- Marketing authorisation holder: PLIVA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1989
- Application: ANDA072124
- Marketing authorisation holder: PLIVA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 1990
- Application: NDA019614
- Marketing authorisation holder: AZURITY
- Local brand name: VERELAN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 July 1992
- Application: ANDA073568
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 February 1993
- Application: ANDA072233
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 1993
- Application: ANDA072923
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 1993
- Application: ANDA073485
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 1994
- Application: ANDA074330
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA072888
- Marketing authorisation holder: BEDFORD
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 1996
- Application: ANDA072751
- Marketing authorisation holder: PLIVA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1996
- Application: NDA020552
- Marketing authorisation holder: PFIZER
- Local brand name: COVERA-HS
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 March 1996
- Application: ANDA072922
- Marketing authorisation holder: PLIVA
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 March 1996
- Application: ANDA074587
- Marketing authorisation holder: RISING
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 April 1999
- Application: ANDA075138
- Marketing authorisation holder: MYLAN
- Status: supplemented
FDA — authorised 26 December 2002
- Application: NDA020943
- Marketing authorisation holder: AZURITY
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 August 2007
- Application: ANDA078306
- Marketing authorisation holder: RISING
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 September 2009
- Application: ANDA078906
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 December 2011
- Application: ANDA090529
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 April 2012
- Application: ANDA200878
- Marketing authorisation holder: APOTEX CORP
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA211035
- Marketing authorisation holder: SOMERSET
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA211015
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 13 July 2018
- Application: ANDA210994
- Marketing authorisation holder: AMNEAL
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 25 March 2020
- Application: ANDA213232
- Marketing authorisation holder: CAPLIN
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA212965
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 15 October 2020
- Application: ANDA214215
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 15 October 2020
- Application: ANDA214361
- Marketing authorisation holder: GLAND
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 2021
- Application: ANDA075136
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA215829
- Marketing authorisation holder: HERITAGE
- Status: approved
FDA — authorised 24 November 2025
- Application: ANDA219252
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Verapamil Hydrochloride Extended Release Tablets, manufactured by ZYDUS LIFESCIENCES, on 24 November 2025. This approval was granted under the standard expedited pathway. The approved indication is for the treatment of various cardiovascular conditions, as specified in the FDA's approval letter. The marketing authorisation holder is ZYDUS LIFESCIENCES, and the local brand name is Verapamil Hydrochloride.
FDA
- Application: ANDA070348
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070696
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070697
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070672
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: VERAPAMIL HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA070695
- Marketing authorisation holder: SOLOPAK
- Local brand name: VERAPAMIL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072799
- Marketing authorisation holder: WATSON LABS
- Local brand name: VERAPAMIL HYDROCHLORIDE
- 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: 3,278
Most-reported reactions
- Hypotension — 385 reports (11.74%)
- Nausea — 385 reports (11.74%)
- Dyspnoea — 383 reports (11.68%)
- Drug Interaction — 361 reports (11.01%)
- Dizziness — 337 reports (10.28%)
- Off Label Use — 303 reports (9.24%)
- Drug Ineffective — 291 reports (8.88%)
- Fatigue — 289 reports (8.82%)
- Diarrhoea — 275 reports (8.39%)
- Completed Suicide — 269 reports (8.21%)
Verapamil Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Verapamil Hydrochloride approved in United States?
Yes. FDA authorised it on 12 November 1985; FDA authorised it on 16 December 1985; FDA authorised it on 20 August 1986.
Who is the marketing authorisation holder for Verapamil Hydrochloride in United States?
LUITPOLD holds the US marketing authorisation.