Orange Book product · Brand (NDA)
NASCOBAL
CYANOCOBALAMIN
At a glance
Jan 31, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2005
21 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CYANOCOBALAMIN
Strength
0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 021642
Product number
001
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
- 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
- —RUBRAMIN PCBrand (NDA)
NDA 006799 · BRISTOL MYERS SQUIBB
- —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.
