FDA Orange Book · active-ingredient family
Folic acid
Folic acid: 3 brands, 38 generics; first approved May 13, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 38 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
38
Listed patents
0
Presentations
42
Brand (NDA) products
Originator applications
- SOLUBIOMIXNDA 2163952026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML SOLUTION ORAL Rx — - FOLVITERLDWYETH PHARMS INCNDA 005897—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 5MG/ML INJECTABLE INJECTION Discontinued — - FOLIC ACIDLILLYNDA 006135—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued —
Generic (ANDA) products (38)
Abbreviated applications
- FOLIC ACIDXGEN PHARMSANDA 2025222019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - FOLIC ACIDRISINGANDA 2110642019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDNUVO PHARMS INCANDA 2044182015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDCADILA PHARMS LTDANDA 2024372014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDAIPING PHARM INCANDA 0911452013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDPH HEALTHANDA 0407562010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDCHARTWELL MOLECULARANDA 0900352009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDLEADINGANDA 0407962009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDRSAMNEAL PHARMANDA 0406252005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDSUN PHARM INDUSTRIESANDA 0405822005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDJUBILANT CADISTAANDA 0405142005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDBEN VENUEANDA 0810661993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - FOLIC ACIDRSFRESENIUS KABI USAANDA 0892021986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Rx AP - FOLIC ACIDBARRANDA 0891771986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDPIONEER PHARMSANDA 0889491985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDVANGARDANDA 0887301984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDUDLANDA 0881991983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDUSL PHARMAANDA 0878281982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDCONTRACT PHARMACALANDA 085061—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDEVERYLIFEANDA 080755—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDHALSEYANDA 083598—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDHIKMA PHARMSANDA 080600—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDIMPAX LABSANDA 080686—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDIVAX SUB TEVA PHARMSANDA 083000—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDLANNETTANDA 080816—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDMK LABSANDA 083526—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDNEXGEN PHARMA INCANDA 084915—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDPHARMERALANDA 084158—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDPUREPAC PHARMANDA 080784—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDSANDOZANDA 084472—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDTABLICAPSANDA 083133—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDVALEANT PHARM INTLANDA 080903—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDVINTAGE PHARMSANDA 086296—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDRLDWATSON LABSANDA 080680—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - FOLIC ACIDWATSON LABSANDA 083141—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDWATSON LABSANDA 085141—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FOLIC ACIDWHITEWORTH TOWN PLSNANDA 080691—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - MISSION PHARMAANDA 087438—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
45 yr 1 mo ago
Most recent approval
8 mo ago
Approvals span 1982–2026 across 41 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 3893%
Folic acid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
