Sarepta Therapeutics
FDA Approved Drugs

Sarepta 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
  • Total Records 4
  • Latest Approval Date Feb 25, 2021
  • Data Source FDA
  • First Approval Date Sep 19, 2016
Company Overview

Company

Sarepta Therapeutics

Country

U.S.A

Website

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Email

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Company Snapshot

Sarepta Therapeutics

215 First Street Cambridge, MA 02142

U.S.A

www.sarepta.com/ View on Map
FDA Approved Drug Records ( 4 records )
2021
25 Feb
RX Application: 213026

Drug Name

AMONDYS 45

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2021-02-25

213026 / 1

Active Ingredient

CASIMERSEN

Application Number

213026

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2021-02-25

Regulatory Status

RX

2016
19 Sep
RX Application: 206488

Drug Name

EXONDYS 51

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2016-09-19

206488 / 1

Active Ingredient

ETEPLIRSEN

Application Number

206488

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2016-09-19

Regulatory Status

RX

2016
19 Sep
RX Application: 206488

Drug Name

EXONDYS 51

Product Number

2

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2016-09-19

206488 / 2

Active Ingredient

ETEPLIRSEN

Application Number

206488

Product Number

2

Dosage Form

-

Strength

500MG/10ML (50MG/ML)

Approval Date

2016-09-19

Regulatory Status

RX

2019
12 Dec
RX Application: 211970

Drug Name

VYONDYS 53

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2019-12-12

211970 / 1

Active Ingredient

GOLODIRSEN

Application Number

211970

Product Number

1

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

Approval Date

2019-12-12

Regulatory Status

RX

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Drug Status Breakdown
4 total
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

AMONDYS 45

Application Number

213026

Product Number

1

Active Ingredient

CASIMERSEN

Dosage Form

-

Strength

100MG/2ML (50MG/ML)

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