SpringWorks Therapeutics
FDA Approved Drugs

SpringWorks Therapeutics

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued
  • Total Records 8
  • Latest Approval Date Jul 28, 2026
  • Data Source FDA
  • First Approval Date Nov 27, 2023
All
8
View
Discontinued
1
View
RX
7
View
Company Overview

Company

SpringWorks Therapeutics

Country

U.S.A

Social Profiles

LinkedIn X / Twitter
Company Snapshot

SpringWorks Therapeutics

100 Washington Blvd, Stamford, CT 06902,

U.S.A

springworkstx.com/ info@springworkstx.com View on Map
FDA Approved Drug Records ( 8 records )
2025
11 Feb
RX Application: 219379

Drug Name

GOMEKLI

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-02-11

219379 / 1

Active Ingredient

MIRDAMETINIB

Application Number

219379

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-02-11

Regulatory Status

RX

2026
28 Jul
RX Application: 219379

Drug Name

GOMEKLI

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2026-07-28

219379 / 2

Active Ingredient

MIRDAMETINIB

Application Number

219379

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 219379

Drug Name

GOMEKLI

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2026-07-28

219379 / 3

Active Ingredient

MIRDAMETINIB

Application Number

219379

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2026-07-28

Regulatory Status

RX

2025
11 Feb
RX Application: 219389

Drug Name

GOMEKLI

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-02-11

219389 / 1

Active Ingredient

MIRDAMETINIB

Application Number

219389

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-02-11

Regulatory Status

RX

2025
11 Feb
RX Application: 219389

Drug Name

GOMEKLI

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2025-02-11

219389 / 2

Active Ingredient

MIRDAMETINIB

Application Number

219389

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2025-02-11

Regulatory Status

RX

2023
27 Nov
Discontinued Application: 217677

Drug Name

OGSIVEO

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-11-27

217677 / 1

Active Ingredient

NIROGACESTAT HYDROBROMIDE

Application Number

217677

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2023-11-27

Regulatory Status

Discontinued

2024
04 Apr
RX Application: 217677

Drug Name

OGSIVEO

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-04

217677 / 2

Active Ingredient

NIROGACESTAT HYDROBROMIDE

Application Number

217677

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-04

Regulatory Status

RX

2024
04 Apr
RX Application: 217677

Drug Name

OGSIVEO

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-04-04

217677 / 3

Active Ingredient

NIROGACESTAT HYDROBROMIDE

Application Number

217677

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2024-04-04

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    8 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
8 total
  • RX
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

GOMEKLI

Application Number

219379

Product Number

1

Active Ingredient

MIRDAMETINIB

Dosage Form

-

Strength

1MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.