FDA — authorised 17 December 1965
- Application: ANDA060624
- Marketing authorisation holder: WYETH AYERST
- Local brand name: OMNIPEN (AMPICILLIN)
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 PROBAMPACIN in United States
FDA authorised PROBAMPACIN on 17 December 1965
Marketing authorisations
FDA — authorised 7 May 1970
- Application: ANDA060666
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 March 1971
- Application: ANDA061392
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: PRINCIPEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 March 1971
- Application: ANDA061394
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 August 1971
- Application: ANDA061370
- Marketing authorisation holder: TEVA
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 November 1971
- Application: ANDA061502
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 January 1974
- Application: ANDA061602
- Marketing authorisation holder: BELCHER PHARMS
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 1974
- Application: ANDA061601
- Marketing authorisation holder: BELCHER PHARMS
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 December 1974
- Application: ANDA061898
- Marketing authorisation holder: APOTHECON
- Local brand name: POLYCILLIN-PRB
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 May 1976
- Application: ANDA061980
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 July 1977
- Application: ANDA062050
- Marketing authorisation holder: PFIZER
- Local brand name: PFIZERPEN-A
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 December 1977
- Application: ANDA062049
- Marketing authorisation holder: PFIZER
- Local brand name: PFIZERPEN-A
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 August 1979
- Application: ANDA062212
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 August 1979
- Application: ANDA062223
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TOTACILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 February 1988
- Application: ANDA062882
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 February 1988
- Application: ANDA062883
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 March 1988
- Application: ANDA062888
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 February 1989
- Application: ANDA062982
- Marketing authorisation holder: PH HEALTH
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 October 2023
- Application: ANDA216554
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060127
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN '250'
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062041
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: AMCILL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA061387
- Marketing authorisation holder: VITARINE
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062030
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: AMCILL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA050308
- Marketing authorisation holder: BRISTOL
- Local brand name: POLYCILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA050310
- Marketing authorisation holder: BRISTOL
- Local brand name: POLYCILLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA050019
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PENBRITIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA060625
- Marketing authorisation holder: WYETH AYERST
- Local brand name: OMNIPEN (AMPICILLIN)
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062151
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN '250'
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062157
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN '500'
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA050056
- Marketing authorisation holder: APOTHECON
- Local brand name: PRINCIPEN '500'
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060765
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA050093
- Marketing authorisation holder: BRISTOL
- Local brand name: POLYCILLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA
- Application: ANDA062208
- Marketing authorisation holder: LEDERLE
- Local brand name: AMPICILLIN TRIHYDRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA060908
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PENBRITIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062297
- Marketing authorisation holder: APOTHECON
- Local brand name: POLYCILLIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
PROBAMPACIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is PROBAMPACIN approved in United States?
Yes. FDA authorised it on 17 December 1965; FDA authorised it on 7 May 1970; FDA authorised it on 3 March 1971.
Who is the marketing authorisation holder for PROBAMPACIN in United States?
WYETH AYERST holds the US marketing authorisation.