Amgen Inc RX
FDA Approved Drugs

Amgen Inc RX

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
  • Total Records 8
  • Latest Approval Date Aug 29, 2025
  • Data Source FDA
  • First Approval Date Mar 21, 2014
All
66
View
Unclassified
50
View
Discontinued
8
View
RX
8
View
Company Overview

Company

Amgen Inc RX

Country

U.S.A

Social Profiles

Company Snapshot

Amgen Inc RX

One Amgen Center Drive, Thousand Oaks, CA91320-1799

U.S.A

www.amgen.com/ amgenfoundation@amgen.com View on Map
FDA Approved Drug Records ( 8 records )
2021
28 May
RX Application: 214665

Drug Name

LUMAKRAS

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2021-05-28

214665 / 1

Active Ingredient

SOTORASIB

Application Number

214665

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2021-05-28

Regulatory Status

RX

2023
20 Jan
RX Application: 214665

Drug Name

LUMAKRAS

Product Number

2

Dosage Form

-

Strength

320MG

Approval Date

2023-01-20

214665 / 2

Active Ingredient

SOTORASIB

Application Number

214665

Product Number

2

Dosage Form

-

Strength

320MG

Approval Date

2023-01-20

Regulatory Status

RX

2024
26 Jun
RX Application: 214665

Drug Name

LUMAKRAS

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2024-06-26

214665 / 3

Active Ingredient

SOTORASIB

Application Number

214665

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2024-06-26

Regulatory Status

RX

2014
21 Mar
RX Application: 205437

Drug Name

OTEZLA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2014-03-21

205437 / 1

Active Ingredient

APREMILAST

Application Number

205437

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2014-03-21

Regulatory Status

RX

2014
21 Mar
RX Application: 205437

Drug Name

OTEZLA

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2014-03-21

205437 / 2

Active Ingredient

APREMILAST

Application Number

205437

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2014-03-21

Regulatory Status

RX

2014
21 Mar
RX Application: 205437

Drug Name

OTEZLA

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2014-03-21

205437 / 3

Active Ingredient

APREMILAST

Application Number

205437

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2014-03-21

Regulatory Status

RX

2025
29 Aug
RX Application: 210745

Drug Name

OTEZLA XR

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2025-08-29

210745 / 1

Active Ingredient

APREMILAST

Application Number

210745

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2025-08-29

Regulatory Status

RX

2021
07 Oct
RX Application: 214487

Drug Name

TAVNEOS

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-10-07

214487 / 1

Active Ingredient

AVACOPAN

Application Number

214487

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-10-07

Regulatory Status

RX

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Drug Status Breakdown
8 total
  • RX
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

LUMAKRAS

Application Number

214665

Product Number

1

Active Ingredient

SOTORASIB

Dosage Form

-

Strength

120MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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