Biogen RX
FDA Approved Drugs

Biogen 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 9
  • Latest Approval Date Mar 27, 2026
  • Data Source FDA
  • First Approval Date Mar 27, 2013
All
15
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Unclassified
6
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RX
9
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Company Overview

Company

Biogen RX

Country

U.S.A

Website

Visit Website

Email

medinfo@biogen.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Biogen RX

225 Binney Street Cambridge, MA 02142

U.S.A

www.biogen.com/ medinfo@biogen.com View on Map
FDA Approved Drug Records ( 9 records )
2016
23 Dec
RX Application: 209531

Drug Name

SPINRAZA

Product Number

1

Dosage Form

-

Strength

EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

Approval Date

2016-12-23

209531 / 1

Active Ingredient

NUSINERSEN SODIUM

Application Number

209531

Product Number

1

Dosage Form

-

Strength

EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

Approval Date

2016-12-23

Regulatory Status

RX

2026
27 Mar
RX Application: 209531

Drug Name

SPINRAZA

Product Number

2

Dosage Form

-

Strength

EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)

Approval Date

2026-03-27

209531 / 2

Active Ingredient

NUSINERSEN SODIUM

Application Number

209531

Product Number

2

Dosage Form

-

Strength

EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)

Approval Date

2026-03-27

Regulatory Status

RX

2026
27 Mar
RX Application: 209531

Drug Name

SPINRAZA

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

Approval Date

2026-03-27

209531 / 3

Active Ingredient

NUSINERSEN SODIUM

Application Number

209531

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

Approval Date

2026-03-27

Regulatory Status

RX

2013
27 Mar
RX Application: 204063

Drug Name

TECFIDERA

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2013-03-27

204063 / 1

Active Ingredient

DIMETHYL FUMARATE

Application Number

204063

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2013-03-27

Regulatory Status

RX

2013
27 Mar
RX Application: 204063

Drug Name

TECFIDERA

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2013-03-27

204063 / 2

Active Ingredient

DIMETHYL FUMARATE

Application Number

204063

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2013-03-27

Regulatory Status

RX

2019
29 Oct
RX Application: 211855

Drug Name

VUMERITY

Product Number

1

Dosage Form

-

Strength

231MG

Approval Date

2019-10-29

211855 / 1

Active Ingredient

DIROXIMEL FUMARATE

Application Number

211855

Product Number

1

Dosage Form

-

Strength

231MG

Approval Date

2019-10-29

Regulatory Status

RX

2023
31 Oct
RX Application: 217369

Drug Name

ZURZUVAE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-10-31

217369 / 1

Active Ingredient

ZURANOLONE

Application Number

217369

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-10-31

Regulatory Status

RX

2023
31 Oct
RX Application: 217369

Drug Name

ZURZUVAE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2023-10-31

217369 / 2

Active Ingredient

ZURANOLONE

Application Number

217369

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2023-10-31

Regulatory Status

RX

2023
31 Oct
RX Application: 217369

Drug Name

ZURZUVAE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-10-31

217369 / 3

Active Ingredient

ZURANOLONE

Application Number

217369

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-10-31

Regulatory Status

RX

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Drug Status Breakdown
9 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

SPINRAZA

Application Number

209531

Product Number

1

Active Ingredient

NUSINERSEN SODIUM

Dosage Form

-

Strength

EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

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

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