Biogen
FDA Approved Drugs

Biogen

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.

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

Company

Biogen

Country

U.S.A

Website

Visit Website

Email

medinfo@biogen.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Biogen

225 Binney Street Cambridge, MA 02142

U.S.A

www.biogen.com/ medinfo@biogen.com View on Map
FDA Approved Drug Records ( 15 records )
-
Unclassified Application: 761178

Drug Name

ADUHELM

Product Number

1

Dosage Form

-

Strength

170MG/1.7ML (100MG/ML)

Approval Date

-

761178 / 1

Active Ingredient

ADUCANUMAB-AVWA

Application Number

761178

Product Number

1

Dosage Form

-

Strength

170MG/1.7ML (100MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761178

Drug Name

ADUHELM

Product Number

2

Dosage Form

-

Strength

300MG/3ML (100MG/ML)

Approval Date

-

761178 / 2

Active Ingredient

ADUCANUMAB-AVWA

Application Number

761178

Product Number

2

Dosage Form

-

Strength

300MG/3ML (100MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 103628

Drug Name

AVONEX

Product Number

1

Dosage Form

-

Strength

30UG/ML

Approval Date

-

103628 / 1

Active Ingredient

INTERFERON BETA-1A

Application Number

103628

Product Number

1

Dosage Form

-

Strength

30UG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125499

Drug Name

PLEGRIDY

Product Number

1

Dosage Form

-

Strength

125MICROGRAMS/0.5ML

Approval Date

-

125499 / 1

Active Ingredient

PEGINTERFERON BETA-1A

Application Number

125499

Product Number

1

Dosage Form

-

Strength

125MICROGRAMS/0.5ML

Approval Date

-

Regulatory Status

Unclassified

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

-
Unclassified Application: 125104

Drug Name

TYSABRI

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

125104 / 1

Active Ingredient

NATALIZUMAB

Application Number

125104

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

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

-
Unclassified Application: 761029

Drug Name

ZINBRYTA

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

761029 / 1

Active Ingredient

DACLIZUMAB

Application Number

761029

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

-

Regulatory Status

Unclassified

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

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    2 View
  • FDA Approved Drugs Database
    15 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
15 total
  • Unclassified
  • 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

ADUHELM

Application Number

761178

Product Number

1

Active Ingredient

ADUCANUMAB-AVWA

Dosage Form

-

Strength

170MG/1.7ML (100MG/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

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.
Login to Submit