Spectrum Pharmaceuticals
FDA Approved Drugs

Spectrum 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.

Discontinued Unclassified
  • Total Records 5
  • Latest Approval Date Jul 29, 2016
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
5
View
Unclassified
2
View
Discontinued
3
View
Company Overview

Company

Spectrum Pharmaceuticals

Country

U.S.A

Website

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Company Snapshot

Spectrum Pharmaceuticals

11500 S. Eastern Avenue #240 Henderson, NV 89052

U.S.A

www.sppirx.com/ View on Map
FDA Approved Drug Records ( 5 records )
1982
01 Jan
Discontinued Application: 12209

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12209 / 1

Active Ingredient

FLUOROURACIL

Application Number

12209

Product Number

1

Dosage Form

-

Strength

500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2016
29 Jul
Discontinued Application: 12209

Drug Name

FLUOROURACIL

Product Number

2

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-07-29

12209 / 2

Active Ingredient

FLUOROURACIL

Application Number

12209

Product Number

2

Dosage Form

-

Strength

2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-07-29

Regulatory Status

Discontinued

1982
13 Oct
Discontinued Application: 87792

Drug Name

FLUOROURACIL

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-10-13

87792 / 1

Active Ingredient

FLUOROURACIL

Application Number

87792

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-10-13

Regulatory Status

Discontinued

-
Unclassified Application: 761148

Drug Name

ROLVEDON

Product Number

1

Dosage Form

-

Strength

13.2MG/0.6ML

Approval Date

-

761148 / 1

Active Ingredient

EFLAPEGRASTIM-XNST

Application Number

761148

Product Number

1

Dosage Form

-

Strength

13.2MG/0.6ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125019

Drug Name

ZEVALIN

Product Number

1

Dosage Form

-

Strength

3.2MG/2ML

Approval Date

-

125019 / 1

Active Ingredient

IBRITUMOMAB TIUXETAN

Application Number

125019

Product Number

1

Dosage Form

-

Strength

3.2MG/2ML

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
5 total
  • Discontinued
  • Unclassified
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

FLUOROURACIL

Application Number

12209

Product Number

1

Active Ingredient

FLUOROURACIL

Dosage Form

-

Strength

500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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