FDA — authorised 11 October 1965
- Application: NDA050199
- Marketing authorisation holder: WYETH AYERST
- Local brand name: UNIPEN
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Nallpen In Plastic Container in United States
FDA authorised Nallpen In Plastic Container on 11 October 1965
Marketing authorisations
FDA — authorised 7 April 1970
- Application: NDA050111
- Marketing authorisation holder: WYETH AYERST
- Local brand name: UNIPEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 June 1970
- Application: NDA050320
- Marketing authorisation holder: WYETH AYERST
- Local brand name: UNIPEN IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 1984
- Application: ANDA062527
- Marketing authorisation holder: SANDOZ
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1986
- Application: ANDA062755
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: NALLPEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 1986
- Application: ANDA062732
- Marketing authorisation holder: SANDOZ
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 September 1988
- Application: ANDA063008
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 1989
- Application: NDA050655
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: NALLPEN IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 April 2011
- Application: ANDA090005
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2011
- Application: ANDA090002
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 October 2011
- Application: ANDA090560
- Marketing authorisation holder: ANTIBIOTICE
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 August 2012
- Application: ANDA090580
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 August 2012
- Application: ANDA090582
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 2012
- Application: ANDA091614
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 2012
- Application: ANDA091613
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA200002
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 December 2019
- Application: ANDA206682
- Marketing authorisation holder: FRESENIUS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 June 2020
- Application: ANDA206761
- Marketing authorisation holder: FRESENIUS
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA061999
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: NALLPEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062717
- Marketing authorisation holder: WYETH AYERST
- Local brand name: UNIPEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA061984
- Marketing authorisation holder: APOTHECON
- Local brand name: NAFCILLIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
Nallpen In Plastic Container in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Nallpen In Plastic Container approved in United States?
Yes. FDA authorised it on 11 October 1965; FDA authorised it on 7 April 1970; FDA authorised it on 23 June 1970.
Who is the marketing authorisation holder for Nallpen In Plastic Container in United States?
WYETH AYERST holds the US marketing authorisation.