FDA — authorised 10 February 1958
- Application: NDA011210
- Marketing authorisation holder: PFIZER
- Local brand name: TESSALON
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Tessalon in United States
FDA authorised Tessalon on 10 February 1958
Marketing authorisations
FDA — authorised 29 January 1993
- Application: ANDA081297
- Marketing authorisation holder: BIONPHARMA
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 March 2007
- Application: ANDA040627
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 June 2007
- Application: ANDA040597
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 July 2007
- Application: ANDA040749
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 2007
- Application: ANDA040682
- Marketing authorisation holder: HERITAGE PHARMS LABS
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 March 2008
- Application: ANDA040587
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 2009
- Application: ANDA040851
- Marketing authorisation holder: MIKART
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 September 2014
- Application: ANDA201209
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 January 2015
- Application: ANDA091310
- Marketing authorisation holder: ACELLA
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 2015
- Application: ANDA091133
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 2015
- Application: ANDA202765
- Marketing authorisation holder: CSPC-NBP PHARM
- Status: approved
FDA — authorised 9 November 2018
- Application: ANDA210562
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 December 2018
- Application: ANDA206948
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA211518
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 March 2026
- Application: ANDA220298
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: BENZONATATE
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Tessalon (Benzonatate) capsules for oral administration on 30 March 2026. Marksans Pharma is the marketing authorisation holder. The approval was granted through the standard expedited pathway. Tessalon is indicated for the treatment of cough.
Tessalon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Tessalon approved in United States?
Yes. FDA authorised it on 10 February 1958; FDA authorised it on 29 January 1993; FDA authorised it on 30 March 2007.
Who is the marketing authorisation holder for Tessalon in United States?
PFIZER holds the US marketing authorisation.