FDA Orange Book
Generic for Folvite
Folvite contains folic acid. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Folvite is folic acid. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Folvite products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/ML | Discontinued | None | 2 | AP |
| tablet, oral | 1MG | Discontinued | None | 8 | AA |
NDA 005897, held by WYETH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic folic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 089202 | AP (A-rated, therapeutically equivalent) | February 18, 1986 | 5MG/ML |
| AMNEAL PHARMACEUTICAL | 040625 | AA (A-rated, therapeutically equivalent) | July 21, 2005 | 1MG |
| LEADING PHARMA LLC | 040796 | AA (A-rated, therapeutically equivalent) | January 12, 2009 | 1MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 090035 | AA (A-rated, therapeutically equivalent) | June 9, 2009 | 1MG |
| AIPING PHARMACEUTICAL INC | 091145 | AA (A-rated, therapeutically equivalent) | July 12, 2013 | 1MG |
| CADILA PHARMACEUTICALS LTD | 202437 | AA (A-rated, therapeutically equivalent) | January 27, 2014 | 1MG |
| NUVO PHAMACEUTICALS INC | 204418 | AA (A-rated, therapeutically equivalent) | July 28, 2015 | 1MG |
| RISING PHARMA HOLDINGS INC | 211064 | AA (A-rated, therapeutically equivalent) | March 8, 2019 | 1MG |
| XGEN PHARMACEUTICALS DJB INC | 202522 | AP (A-rated, therapeutically equivalent) | November 6, 2019 | 5MG/ML |
| WATSON LABORATORIES | 080680 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1MG |
Questions
Is there a generic for Folvite?
Yes. The generic name for Folvite is folic acid. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Folvite?
The active ingredient in Folvite is folic acid, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.