Wednesday, July 8, 2026

Drug profile · INN

folic acid

folic acid (FOLTABS 500) is an FDA-listed pharmaceutical active ingredient. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn TGA: approved Various (V04) V04
US status approved
Patents linked 3
Pipeline programs 13
News articles 0
Drug details — folic acid
US status
approved
Class
Various (V04)
Route
INJECTION
Patents
3
Programs
13
Data quality
0.89

Quick answer

folic acid (FOLTABS 500) is an FDA-listed pharmaceutical active ingredient. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN folic acid
Brand FOLTABS 500
Therapeutic class Various (V04)
Route INJECTION
Formulation INJECTABLE
ATC code V04

Approval history

Authority Status Date
FDA approved
EMA application withdrawn
TGA approved

Pipeline programs

  1. CT-P13 3.11 Phase 3 · Celltrion Healthcare Australia · Rheumatoid arthritis
  2. D20180177 Phase 3 · PARItec · Pancreatic adenocarcinoma (PAC)
  3. Iron (27 mg) - folic acid (600 ug) Phase 3 · United Therapeutics Europe · Infant Mortality
  4. MC-MTX.18/AD Phase 3 · Medac Gesellschaft fuer · moderate to severe atopic dermatitis
  5. folic acid Phase 3 · Chinese Academy of · Colorectal Neoplasms
  6. IKF/AIO-ZANGEA Phase 2 · George Institute for · Gastroesophageal Adenocarcinoma
  7. Folic Acid 5 MG Phase 1 · University of Hong · Acute Kidney Injury
  8. Folic Acid Approved · First People's Hospital · Hypertension

Related & competitor drugs

  1. besilesomab Various (V09)
  2. deferasirox Various (V03)
  3. ferric citrate coordination complex Various (V03)
  4. sevelamer carbonate Various (V03)
  5. sugammadex sodium Various (V03)
  6. cobicistat Various (V03)
  1. US 12084419

    Cell metabolism modulating compounds and uses thereof

    Expires Mon Sep 05 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12013406

    Methods of detecting anti-folic acid antibodies and uses thereof

    Expires Mon Jun 13 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11313868

    Methods of detecting anti-folic acid antibodies and uses thereof

    Expires Mon Apr 21 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is folic acid?

folic acid (FOLTABS 500) is an FDA-listed pharmaceutical active ingredient. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for folic acid?

FOLTABS 500 is a marketed brand name for folic acid. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of folic acid?

folic acid has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.