Orange Book product · Brand (NDA)
RUBRAMIN PC
CYANOCOBALAMIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CYANOCOBALAMIN
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 006799
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007CALOMISTBrand (NDA)
NDA 022102 · PH HEALTH
- 2005NASCOBALBrand (NDA)
NDA 021642 · ENDO OPERATIONS
- 1996NASCOBALBrand (NDA)
NDA 019722 · ENDO OPERATIONS
- —BERUBIGENBrand (NDA)
NDA 006798 · PHARMACIA AND UPJOHN
- —CYANOCOBALAMINBrand (NDA)
NDA 007085 · WARNER CHILCOTT
- —REDISOLBrand (NDA)
NDA 006668 · MERCK
- —RUBIVITEBrand (NDA)
NDA 010791 · BEL MAR
- —VI-TWELBrand (NDA)
NDA 007012 · BAYER HLTHCARE
- 2024CYANOCOBALAMINGeneric (ANDA)
ANDA 214316 · MEITHEAL
- 2024CYANOCOBALAMINGeneric (ANDA)
ANDA 217839 · MANKIND PHARMA
- 2023CYANOCOBALAMINGeneric (ANDA)
ANDA 210629 · LUPIN
- 2022CYANOCOBALAMINGeneric (ANDA)
ANDA 215107 · SAGENT PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
