BioCryst Pharmaceuticals
FDA Approved Drugs

BioCryst Pharmaceuticals

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 7
  • Latest Approval Date Dec 11, 2025
  • Data Source FDA
  • First Approval Date Dec 19, 2014
Company Overview

Company

BioCryst Pharmaceuticals

Country

U.S.A

Email

Social Profiles

LinkedIn X / Twitter
Company Snapshot

BioCryst Pharmaceuticals

4505 Emperor Blvd., Suite 200 Durham, NC 27703

U.S.A

www.biocryst.com/ View on Map
FDA Approved Drug Records ( 7 records )
2020
03 Dec
RX Application: 214094

Drug Name

ORLADEYO

Product Number

1

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2020-12-03

214094 / 1

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

214094

Product Number

1

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2020-12-03

Regulatory Status

RX

2020
03 Dec
RX Application: 214094

Drug Name

ORLADEYO

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-12-03

214094 / 2

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

214094

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-12-03

Regulatory Status

RX

2025
11 Dec
RX Application: 219776

Drug Name

ORLADEYO

Product Number

1

Dosage Form

-

Strength

EQ 72MG BASE/PACKET

Approval Date

2025-12-11

219776 / 1

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

219776

Product Number

1

Dosage Form

-

Strength

EQ 72MG BASE/PACKET

Approval Date

2025-12-11

Regulatory Status

RX

2025
11 Dec
RX Application: 219776

Drug Name

ORLADEYO

Product Number

2

Dosage Form

-

Strength

EQ 96MG BASE/PACKET

Approval Date

2025-12-11

219776 / 2

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

219776

Product Number

2

Dosage Form

-

Strength

EQ 96MG BASE/PACKET

Approval Date

2025-12-11

Regulatory Status

RX

2025
11 Dec
RX Application: 219776

Drug Name

ORLADEYO

Product Number

3

Dosage Form

-

Strength

EQ 108MG BASE/PACKET

Approval Date

2025-12-11

219776 / 3

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

219776

Product Number

3

Dosage Form

-

Strength

EQ 108MG BASE/PACKET

Approval Date

2025-12-11

Regulatory Status

RX

2025
11 Dec
RX Application: 219776

Drug Name

ORLADEYO

Product Number

4

Dosage Form

-

Strength

EQ 132MG BASE/PACKET

Approval Date

2025-12-11

219776 / 4

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Application Number

219776

Product Number

4

Dosage Form

-

Strength

EQ 132MG BASE/PACKET

Approval Date

2025-12-11

Regulatory Status

RX

2014
19 Dec
RX Application: 206426

Drug Name

RAPIVAB

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2014-12-19

206426 / 1

Active Ingredient

PERAMIVIR

Application Number

206426

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2014-12-19

Regulatory Status

RX

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Drug Status Breakdown
7 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

ORLADEYO

Application Number

214094

Product Number

1

Active Ingredient

BEROTRALSTAT DIHYDROCHLORIDE

Dosage Form

-

Strength

EQ 110MG BASE

FDA Approved Drug Data

Approved drug product information

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