FDA — authorised 15 September 1949
- Status: approved
🇺🇸 Rubramin Pc in United States
FDA authorised Rubramin Pc on 15 September 1949
Marketing authorisations
FDA — authorised 29 September 1950
- Application: NDA006799
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: RUBRAMIN PC
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 July 1958
- Application: NDA010791
- Marketing authorisation holder: BEL MAR
- Local brand name: RUBIVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 1971
- Application: ANDA080515
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 September 1972
- Application: ANDA083022
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DODEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 March 1973
- Application: ANDA080554
- Marketing authorisation holder: WYETH AYERST
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 1973
- Application: ANDA080557
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 1973
- Application: ANDA080689
- Marketing authorisation holder: DELL LABS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 1974
- Application: ANDA080573
- Marketing authorisation holder: DR REDDYS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 1974
- Application: ANDA084264
- Marketing authorisation holder: WEST WARD
- Local brand name: CYANOCOBALAMIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 1974
- Application: NDA017406
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: DICOPAC KIT
- Indication: N/A — N/A
- Status: approved
FDA — authorised 7 April 1982
- Application: ANDA080564
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 1992
- Application: ANDA080737
- Marketing authorisation holder: AM REGENT
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 November 1996
- Application: NDA019722
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: NASCOBAL
- Indication: GEL, METERED — NASAL
- Status: approved
FDA — authorised 27 July 2007
- Application: NDA022102
- Marketing authorisation holder: PH HEALTH
- Local brand name: CALOMIST
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 6 June 2014
- Application: NDA021642
- Marketing authorisation holder: ENDO OPERATIONS
- Status: approved
FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA204829
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2018
- Application: ANDA209429
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 2020
- Application: ANDA212458
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CYANOCOBALAMIN
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA214390
- Marketing authorisation holder: GLAND
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 October 2020
- Application: ANDA206503
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 8 December 2020
- Application: ANDA213874
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 January 2021
- Application: ANDA212915
- Marketing authorisation holder: SANDOZ
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA215417
- Marketing authorisation holder: SOLA PHARMS
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA215107
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 2024
- Application: ANDA217839
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2024
- Application: ANDA214316
- Marketing authorisation holder: MEITHEAL
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080668
- Marketing authorisation holder: LUITPOLD
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080570
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: RUVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083013
- Marketing authorisation holder: WATSON LABS
- Local brand name: COBAVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080510
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087969
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA006668
- Marketing authorisation holder: MERCK
- Local brand name: REDISOL
- Indication: INJECTABLE — INJECTION
- Status: approved
Rubramin Pc in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Rubramin Pc approved in United States?
Yes. FDA authorised it on 15 September 1949; FDA authorised it on 29 September 1950; FDA authorised it on 14 July 1958.
Who is the marketing authorisation holder for Rubramin Pc in United States?
Marketing authorisation holder not available in our data.