FDA — authorised 9 May 1972
- Application: ANDA080779
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tussionex Pennkinetic in United States
FDA authorised Tussionex Pennkinetic on 9 May 1972
Marketing authorisations
FDA — authorised 24 August 1972
- Application: ANDA080700
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1972
- Application: ANDA080961
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1973
- Application: ANDA083381
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: ANTAGONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 1973
- Application: ANDA083787
- Marketing authorisation holder: WEST WARD
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 1973
- Application: ANDA080821
- Marketing authorisation holder: BEL MAR
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 June 1974
- Application: ANDA083753
- Marketing authorisation holder: PHARMERAL
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 1974
- Application: ANDA080696
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 1977
- Application: ANDA085104
- Marketing authorisation holder: PHARMAVITE
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 1977
- Application: ANDA083593
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 January 1979
- Application: ANDA083733
- Marketing authorisation holder: BEL MAR
- Local brand name: PYRIDAMAL 100
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 February 1979
- Application: ANDA086519
- Marketing authorisation holder: NEWTRON PHARMS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 1979
- Application: ANDA086096
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 1981
- Application: ANDA087164
- Marketing authorisation holder: KV PHARM
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1984
- Application: ANDA088556
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 1985
- Application: NDA018843
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 1985
- Application: NDA018844
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 April 1985
- Application: NDA018794
- Marketing authorisation holder: GRAHAM DM
- Local brand name: COLD CAPSULE V
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 April 1985
- Application: NDA018793
- Marketing authorisation holder: GRAHAM DM
- Local brand name: COLD CAPSULE IV
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 July 1987
- Application: ANDA085139
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1988
- Application: NDA019428
- Marketing authorisation holder: CENT PHARMS
- Local brand name: PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 August 1988
- Application: ANDA070797
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 November 1994
- Application: NDA019746
- Marketing authorisation holder: ALZA
- Local brand name: EFIDAC 24 CHLORPHENIRAMINE MALEATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 December 2002
- Application: NDA021441
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL ALLERGY SINUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2004
- Application: NDA021587
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: CHILDREN'S ADVIL ALLERGY SINUS
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 May 2009
- Application: ANDA040829
- Marketing authorisation holder: AVANTHI INC
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 June 2011
- Application: NDA022439
- Marketing authorisation holder: PERSION
- Local brand name: ZUTRIPRO
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 December 2011
- Application: NDA022113
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL MULTI-SYMPTOM COLD & FLU
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2015
- Application: ANDA206438
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 June 2015
- Application: NDA206323
- Marketing authorisation holder: MAINPOINTE
- Local brand name: TUXARIN ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 June 2017
- Application: ANDA206891
- Marketing authorisation holder: ACELLA
- Local brand name: HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: NDA018115
- Marketing authorisation holder: NOVARTIS
- Local brand name: TRIAMINIC-12
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA080938
- Marketing authorisation holder: ELKINS SINN
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083062
- Marketing authorisation holder: BELL PHARMA
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083078
- Marketing authorisation holder: ANABOLIC
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086095
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018935
- Marketing authorisation holder: SCHWARZ PHARMA
- Local brand name: CODIMAL-L.A. 12
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA017369
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TELDRIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA080809
- Marketing authorisation holder: IMPAX LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080791
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080626
- Marketing authorisation holder: ROXANE
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080786
- Marketing authorisation holder: PVT FORM
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083629
- Marketing authorisation holder: HALSEY
- Local brand name: KLOROMIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071455
- Marketing authorisation holder: KV PHARM
- Local brand name: PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087520
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA080797
- Marketing authorisation holder: ELKINS SINN
- Local brand name: CHLORPHENIRAMINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Tussionex Pennkinetic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Tussionex Pennkinetic approved in United States?
Yes. FDA authorised it on 9 May 1972; FDA authorised it on 24 August 1972; FDA authorised it on 20 December 1972.
Who is the marketing authorisation holder for Tussionex Pennkinetic in United States?
IVAX SUB TEVA PHARMS holds the US marketing authorisation.