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RUBRAMIN PC

NDA

CYANOCOBALAMIN | N006799 | BRISTOL MYERS SQUIBB CO

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCECYANOCOBALAMIN

DMF 40951981

HEBEI YUXING BIO-ENGINEERING CO LTDCYANOCOBALAMIN

DMF 213912008

HEBEI HUARONG PHARMACEUTICAL CO LTDCYANOCOBALAMIN

DMF 361912021

FARMITALIA SPAInactiveCYANOCOBALAMIN (VITAMIN B 12)

DMF 32221978

SANOFI CHIMIEInactiveCYANOCOBALAMIN PH. EUR. USP, JP

DMF 51381983

ANTIBIOTICE SAInactiveCYANOCOBALAMIN (VITAMIN B12)

DMF 165562003

WOCKHARDT LTDInactiveCYANOCOBALAMIN USP

DMF 197022006

HEBEI HUARONG PHARMACEUTICAL CO LTDInactiveCYANOCOBALAMIN

DMF 209732007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#002 — 0.1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#010 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 28, 1988