Orange Book product · Brand (NDA)
FOLVITE
FOLIC ACID
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
FOLIC ACID
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 005897
Product number
008
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.
- 2026QUIOFICBrand (NDA)
NDA 216395 · SOLUBIOMIX
- —FOLIC ACIDBrand (NDA)
NDA 006135 · LILLY
- 2019FOLIC ACIDGeneric (ANDA)
ANDA 202522 · XGEN PHARMS
- 2019FOLIC ACIDGeneric (ANDA)
ANDA 211064 · RISING
- 2015FOLIC ACIDGeneric (ANDA)
ANDA 204418 · NUVO PHARMS INC
- 2014FOLIC ACIDGeneric (ANDA)
ANDA 202437 · CADILA PHARMS LTD
- 2013FOLIC ACIDGeneric (ANDA)
ANDA 091145 · AIPING PHARM INC
- 2010FOLIC ACIDGeneric (ANDA)
ANDA 040756 · PH HEALTH
- 2009FOLIC ACIDGeneric (ANDA)
ANDA 090035 · CHARTWELL MOLECULAR
- 2009FOLIC ACIDGeneric (ANDA)
ANDA 040796 · LEADING
- 2005FOLIC ACIDGeneric (ANDA)
ANDA 040625 · AMNEAL PHARM
- 2005FOLIC ACIDGeneric (ANDA)
ANDA 040582 · SUN PHARM INDUSTRIES
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.
