ESSENTIAL ISOTOPES
FDA Approved Drugs

ESSENTIAL ISOTOPES

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
  • Total Records 3
  • Latest Approval Date Dec 17, 2015
  • Data Source FDA
  • First Approval Date Feb 05, 2014
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Company

ESSENTIAL ISOTOPES

Country

U.S.A

Website

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Company Snapshot

ESSENTIAL ISOTOPES

Essential Isotopes, LLC 1513 Research Park Dr. Columbia, MO 65211

U.S.A

mweichelt@midamericaisotopes.com View on Map
FDA Approved Drug Records ( 3 records )
2015
17 Dec
Discontinued Application: 205687

Drug Name

AMMONIA N 13

Product Number

1

Dosage Form

-

Strength

3.75mCi-260mCi/ML

Approval Date

2015-12-17

205687 / 1

Active Ingredient

AMMONIA N-13

Application Number

205687

Product Number

1

Dosage Form

-

Strength

3.75mCi-260mCi/ML

Approval Date

2015-12-17

Regulatory Status

Discontinued

2014
05 Feb
Discontinued Application: 203946

Drug Name

FLUDEOXYGLUCOSE F18

Product Number

1

Dosage Form

-

Strength

20-300mCi/ML

Approval Date

2014-02-05

203946 / 1

Active Ingredient

FLUDEOXYGLUCOSE F-18

Application Number

203946

Product Number

1

Dosage Form

-

Strength

20-300mCi/ML

Approval Date

2014-02-05

Regulatory Status

Discontinued

2014
29 Oct
Discontinued Application: 204541

Drug Name

SODIUM FLUORIDE F-18

Product Number

1

Dosage Form

-

Strength

10-200mCi/ML

Approval Date

2014-10-29

204541 / 1

Active Ingredient

SODIUM FLUORIDE F-18

Application Number

204541

Product Number

1

Dosage Form

-

Strength

10-200mCi/ML

Approval Date

2014-10-29

Regulatory Status

Discontinued

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Drug Status Breakdown
3 total
  • Discontinued
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

AMMONIA N 13

Application Number

205687

Product Number

1

Active Ingredient

AMMONIA N-13

Dosage Form

-

Strength

3.75mCi-260mCi/ML

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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