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FDA Orange Book · active-ingredient family

Folic acid

Folic acid is approved as 3 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:QUIOFIC · NDA 216395

3

Brand (NDA)

38

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet

ProductApplicantApplicationTEApproved
QUIOFICRLDSOLUBIOMIXNDA 216395—Jan 26, 2026
FOLVITERLD×2WYETH PHARMS INCNDA 005897—Approved Prior to Jan 1, 1982
FOLIC ACIDLILLYNDA 006135—Approved Prior to Jan 1, 1982

Generic (ANDA) products (38)

ProductApplicantApplicationTEApproved
FOLIC ACIDXGEN PHARMSANDA 202522APNov 06, 2019
FOLIC ACIDRISINGANDA 211064AAMar 08, 2019
FOLIC ACIDNUVO PHARMS INCANDA 204418AAJul 28, 2015
FOLIC ACIDCADILA PHARMS LTDANDA 202437AAJan 27, 2014
FOLIC ACIDAIPING PHARM INCANDA 091145AAJul 12, 2013
FOLIC ACIDPH HEALTHANDA 040756—Jun 04, 2010
FOLIC ACIDCHARTWELL MOLECULARANDA 090035AAJun 09, 2009
FOLIC ACIDLEADINGANDA 040796AAJan 12, 2009
FOLIC ACIDAMNEAL PHARMANDA 040625AAJul 21, 2005
FOLIC ACIDSUN PHARM INDUSTRIESANDA 040582—Jul 18, 2005
FOLIC ACIDJUBILANT CADISTAANDA 040514—Jun 14, 2005
FOLIC ACIDBEN VENUEANDA 081066—Dec 29, 1993
FOLIC ACIDFRESENIUS KABI USAANDA 089202APFeb 18, 1986
FOLIC ACIDBARRANDA 089177—Jan 08, 1986
FOLIC ACIDPIONEER PHARMSANDA 088949—Sep 13, 1985
FOLIC ACIDVANGARDANDA 088730—Mar 23, 1984
FOLIC ACIDUDLANDA 088199—Mar 29, 1983
FOLIC ACIDUSL PHARMAANDA 087828—May 13, 1982
FOLIC ACIDCONTRACT PHARMACALANDA 085061—Approved Prior to Jan 1, 1982
FOLIC ACIDEVERYLIFEANDA 080755—Approved Prior to Jan 1, 1982
FOLIC ACIDHALSEYANDA 083598—Approved Prior to Jan 1, 1982
FOLIC ACIDHIKMA PHARMSANDA 080600—Approved Prior to Jan 1, 1982
FOLIC ACIDIMPAX LABSANDA 080686—Approved Prior to Jan 1, 1982
FOLIC ACIDIVAX SUB TEVA PHARMSANDA 083000—Approved Prior to Jan 1, 1982
FOLIC ACIDLANNETTANDA 080816—Approved Prior to Jan 1, 1982
FOLIC ACIDMK LABSANDA 083526—Approved Prior to Jan 1, 1982
FOLIC ACIDNEXGEN PHARMA INCANDA 084915—Approved Prior to Jan 1, 1982
FOLIC ACIDPHARMERALANDA 084158—Approved Prior to Jan 1, 1982
FOLIC ACIDPUREPAC PHARMANDA 080784—Approved Prior to Jan 1, 1982
FOLIC ACIDSANDOZANDA 084472—Approved Prior to Jan 1, 1982
FOLIC ACIDTABLICAPSANDA 083133—Approved Prior to Jan 1, 1982
FOLIC ACIDVALEANT PHARM INTLANDA 080903—Approved Prior to Jan 1, 1982
FOLIC ACIDVINTAGE PHARMSANDA 086296—Approved Prior to Jan 1, 1982
FOLIC ACIDRLDWATSON LABSANDA 080680AAApproved Prior to Jan 1, 1982
FOLIC ACIDWATSON LABSANDA 083141—Approved Prior to Jan 1, 1982
FOLIC ACIDWATSON LABSANDA 085141—Approved Prior to Jan 1, 1982
FOLIC ACIDWHITEWORTH TOWN PLSNANDA 080691—Approved Prior to Jan 1, 1982
FOLICETMISSION PHARMAANDA 087438—Approved Prior to Jan 1, 1982

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.

Folic acid — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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