BioMarin Pharmaceutical
FDA Approved Drugs

BioMarin Pharmaceutical

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 6
  • Latest Approval Date Nov 19, 2021
  • Data Source FDA
  • First Approval Date Dec 13, 2007
Company Overview

Company

BioMarin Pharmaceutical

Country

U.S.A

Social Profiles

LinkedIn
Company Snapshot

BioMarin Pharmaceutical

770 Lindaro Street San Rafael, CA 94901

U.S.A

www.biomarin.com/ support@biomarin-rareconnections.com View on Map
FDA Approved Drug Records ( 6 records )
2007
13 Dec
RX Application: 22181

Drug Name

KUVAN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-12-13

22181 / 1

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

22181

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-12-13

Regulatory Status

RX

2013
19 Dec
RX Application: 205065

Drug Name

KUVAN

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2013-12-19

205065 / 1

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

205065

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2013-12-19

Regulatory Status

RX

2015
27 Oct
RX Application: 205065

Drug Name

KUVAN

Product Number

2

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2015-10-27

205065 / 2

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

205065

Product Number

2

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2015-10-27

Regulatory Status

RX

2021
19 Nov
RX Application: 214938

Drug Name

VOXZOGO

Product Number

1

Dosage Form

-

Strength

0.4MG/VIAL

Approval Date

2021-11-19

214938 / 1

Active Ingredient

VOSORITIDE

Application Number

214938

Product Number

1

Dosage Form

-

Strength

0.4MG/VIAL

Approval Date

2021-11-19

Regulatory Status

RX

2021
19 Nov
RX Application: 214938

Drug Name

VOXZOGO

Product Number

2

Dosage Form

-

Strength

0.56MG/VIAL

Approval Date

2021-11-19

214938 / 2

Active Ingredient

VOSORITIDE

Application Number

214938

Product Number

2

Dosage Form

-

Strength

0.56MG/VIAL

Approval Date

2021-11-19

Regulatory Status

RX

2021
19 Nov
RX Application: 214938

Drug Name

VOXZOGO

Product Number

3

Dosage Form

-

Strength

1.2MG/VIAL

Approval Date

2021-11-19

214938 / 3

Active Ingredient

VOSORITIDE

Application Number

214938

Product Number

3

Dosage Form

-

Strength

1.2MG/VIAL

Approval Date

2021-11-19

Regulatory Status

RX

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Drug Status Breakdown
6 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

KUVAN

Application Number

22181

Product Number

1

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Dosage Form

-

Strength

100MG

FDA Approved Drug Data

Approved drug product information

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