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PROMACTA

eltrombopag olamine · Powder, for Suspension

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PROMACTA
Generic name
eltrombopag olamine
Dosage form
Powder, for Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Novartis Pharmaceuticals Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Eltrombopag Olamine 12.5 mg/1 825421 View
Eltrombopag Olamine 25 mg/1 825421 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder, for Suspension
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Increased Megakaryocyte Maturation [PE] PE 8 members — no class page
Increased Platelet Production [PE] PE 8 members — no class page
Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] MoA All 19 members
Thrombopoietin Receptor Agonist [EPC] EPC 8 members — no class page
Thrombopoietin Receptor Agonists [MoA] MoA 8 members — no class page
UGT1A1 Inhibitors [MoA] MoA All 14 members
UGT1A3 Inhibitors [MoA] MoA 7 members — no class page
UGT1A4 Inhibitors [MoA] MoA 7 members — no class page
UGT1A6 Inhibitors [MoA] MoA 7 members — no class page
UGT1A9 Inhibitors [MoA] MoA All 11 members
UGT2B15 Inhibitors [MoA] MoA 7 members — no class page
UGT2B7 Inhibitors [MoA] MoA All 11 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207027
Application type
NDA · New Drug Application
Approval date
August 24, 2015
Sponsor
NOVARTIS
Products on application
2
Submissions recorded
14
Products approved under application 207027.
Product Trade name Form Strength Ingredient Status TE Flags
207027-001 PROMACTA KIT FOR SUSPENSION ELTROMBOPAG OLAMINE Prescription AB RLD RS
207027-002 PROMACTA KIT FOR SUSPENSION ELTROMBOPAG OLAMINE Prescription AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7547719 July 13, 2025 001 Yes U-1575 September 21, 2015
7547719 July 13, 2025 001 Yes U-1736 September 21, 2015
7547719 July 13, 2025 001 Yes U-2452 September 21, 2015
7547719 July 13, 2025 001 Yes U-1306 September 21, 2015
7547719 July 13, 2025 002 Yes U-2452 April 5, 2019
7547719 July 13, 2025 002 Yes U-1736 April 5, 2019
7547719 July 13, 2025 002 Yes U-1575 April 5, 2019
7547719 July 13, 2025 002 Yes U-1306 April 5, 2019
7547719*PED January 13, 2026 001 No —
7547719*PED January 13, 2026 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 207027.
Type No. Action Status Date Review
Supplement 20 Labeling Approved June 6, 2025 Standard
Supplement 17 Labeling Approved March 9, 2023 Standard
Supplement 15 Labeling Approved March 31, 2022 Standard
Supplement 14 Labeling Approved February 3, 2021 Standard
Supplement 13 Manufacturing (CMC) Approved October 8, 2020 N/A
Supplement 10 Labeling Approved April 29, 2020 Standard
Supplement 8 Labeling Approved April 24, 2019 Standard
Supplement 6 Labeling Approved September 27, 2018 Standard
Supplement 5 Labeling Approved July 24, 2018 Standard
Supplement 4 Labeling Approved May 25, 2018 Standard
Supplement 3 Labeling Approved July 5, 2017 Standard
Supplement 2 Labeling Approved March 9, 2017 Standard
Supplement 1 Labeling Approved October 12, 2016 Standard
Original application 1 Type 3 - New Dosage Form and Type 4 - New Combination Approved August 24, 2015 Priority

Review documents

  • 0 · Supplement · June 9, 2025
  • 0 · Supplement · June 9, 2025
  • 0 · Supplement · June 9, 2025
  • 0 · Supplement · March 10, 2023
  • 0 · Supplement · March 10, 2023
  • 0 · Supplement · April 5, 2022
  • 0 · Supplement · April 4, 2022
  • 0 · Supplement · February 4, 2021
  • 0 · Supplement · February 4, 2021
  • 0 · Supplement · February 4, 2021
  • 0 · Supplement · February 3, 2021
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · April 30, 2020
  • 0 · Supplement · April 25, 2019
  • 0 · Supplement · October 4, 2018
  • 0 · Supplement · October 1, 2018
  • 0 · Supplement · July 26, 2018
  • 0 · Supplement · July 25, 2018
  • 0 · Supplement · May 31, 2018
  • 0 · Supplement · May 30, 2018
  • 0 · Supplement · July 10, 2017
  • 0 · Supplement · March 14, 2017
  • 0 · Supplement · March 10, 2017
  • 0 · Supplement · October 17, 2016
  • 0 · Supplement · October 14, 2016
  • 0 · Original application · June 3, 2016
  • 0 · Original application · June 3, 2016
  • 0 · Original application · August 25, 2015
  • 0 · Original application · August 25, 2015
  • 0 · Supplement · January 1, 1900

Adverse event reports

Source: openFDA FAERS
22,929
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ELTROMBOPAG OLAMINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0078-0697-61 0078-0697 Novartis Pharmaceuticals Corporation 1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) March 27, 2020
0078-0972-61 0078-0972 Novartis Pharmaceuticals Corporation 1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19) September 27, 2018
0078-0697 0078-0697 Novartis Pharmaceuticals Corporation — September 27, 2018
0078-0972 0078-0972 Novartis Pharmaceuticals Corporation — September 27, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.