BTG INTERNATIONAL INC
FDA Approved Drugs

BTG INTERNATIONAL INC

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 Discontinued OTC Unclassified
  • Total Records 8
  • Latest Approval Date Apr 02, 2025
  • Data Source FDA
  • First Approval Date Sep 10, 2002
All
8
View
Unclassified
1
View
Discontinued
1
View
OTC
2
View
RX
4
View
Company Overview

Company

BTG INTERNATIONAL INC

Country

U.S.A

Email

Social Profiles

Company Snapshot

BTG INTERNATIONAL INC

SUITE 800, 300 BARR HARBOR DRIVE

U.S.A

www.btgplc.com/ View on Map
FDA Approved Drug Records ( 8 records )
2024
13 Feb
RX Application: 217933

Drug Name

AURLUMYN

Product Number

1

Dosage Form

-

Strength

100MCG/ML (100MCG/ML)

Approval Date

2024-02-13

217933 / 1

Active Ingredient

ILOPROST

Application Number

217933

Product Number

1

Dosage Form

-

Strength

100MCG/ML (100MCG/ML)

Approval Date

2024-02-13

Regulatory Status

RX

2011
08 Apr
RX Application: 22041

Drug Name

CYANOKIT

Product Number

1

Dosage Form

-

Strength

5GM/VIAL (5GM/KIT)

Approval Date

2011-04-08

22041 / 1

Active Ingredient

HYDROXOCOBALAMIN

Application Number

22041

Product Number

1

Dosage Form

-

Strength

5GM/VIAL (5GM/KIT)

Approval Date

2011-04-08

Regulatory Status

RX

2006
15 Dec
Discontinued Application: 22041

Drug Name

CYANOKIT

Product Number

2

Dosage Form

-

Strength

2.5GM/VIAL (5GM/KIT)

Approval Date

2006-12-15

22041 / 2

Active Ingredient

HYDROXOCOBALAMIN

Application Number

22041

Product Number

2

Dosage Form

-

Strength

2.5GM/VIAL (5GM/KIT)

Approval Date

2006-12-15

Regulatory Status

Discontinued

2002
10 Sep
OTC Application: 76350

Drug Name

THYROSAFE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2002-09-10

76350 / 1

Active Ingredient

POTASSIUM IODIDE

Application Number

76350

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2002-09-10

Regulatory Status

OTC

2025
02 Apr
OTC Application: 76350

Drug Name

THYROSAFE

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2025-04-02

76350 / 2

Active Ingredient

POTASSIUM IODIDE

Application Number

76350

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2025-04-02

Regulatory Status

OTC

2015
11 Dec
RX Application: 208159

Drug Name

VISTOGARD

Product Number

1

Dosage Form

-

Strength

10GM/PACKET

Approval Date

2015-12-11

208159 / 1

Active Ingredient

URIDINE TRIACETATE

Application Number

208159

Product Number

1

Dosage Form

-

Strength

10GM/PACKET

Approval Date

2015-12-11

Regulatory Status

RX

-
Unclassified Application: 125327

Drug Name

VORAXAZE

Product Number

1

Dosage Form

-

Strength

1000 UNITS PER VIAL

Approval Date

-

125327 / 1

Active Ingredient

GLUCARPIDASE

Application Number

125327

Product Number

1

Dosage Form

-

Strength

1000 UNITS PER VIAL

Approval Date

-

Regulatory Status

Unclassified

2015
04 Sep
RX Application: 208169

Drug Name

XURIDEN

Product Number

1

Dosage Form

-

Strength

2GM/PACKET

Approval Date

2015-09-04

208169 / 1

Active Ingredient

URIDINE TRIACETATE

Application Number

208169

Product Number

1

Dosage Form

-

Strength

2GM/PACKET

Approval Date

2015-09-04

Regulatory Status

RX

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Drug Status Breakdown
8 total
  • RX
  • Discontinued
  • OTC
  • Unclassified
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

AURLUMYN

Application Number

217933

Product Number

1

Active Ingredient

ILOPROST

Dosage Form

-

Strength

100MCG/ML (100MCG/ML)

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

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