Ionetix
FDA Approved Drugs

Ionetix

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 2
  • Latest Approval Date May 14, 2026
  • Data Source FDA
  • First Approval Date Dec 21, 2018
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Company

Ionetix

Country

U.S.A

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Ionetix

101 The Embarcadero Suite 210 San Francisco, CA 94105

U.S.A

www.ionetix.com/ N-13Ammonia@IONETIX.com View on Map
FDA Approved Drug Records ( 2 records )
2018
21 Dec
RX Application: 210524

Drug Name

AMMONIA N 13

Product Number

1

Dosage Form

-

Strength

22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)

Approval Date

2018-12-21

210524 / 1

Active Ingredient

AMMONIA N-13

Application Number

210524

Product Number

1

Dosage Form

-

Strength

22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)

Approval Date

2018-12-21

Regulatory Status

RX

2026
14 May
RX Application: 219189

Drug Name

GALLIUM GA 68 GOZETOTIDE

Product Number

1

Dosage Form

-

Strength

0.5-5mCi/ML

Approval Date

2026-05-14

219189 / 1

Active Ingredient

GALLIUM GA-68 GOZETOTIDE

Application Number

219189

Product Number

1

Dosage Form

-

Strength

0.5-5mCi/ML

Approval Date

2026-05-14

Regulatory Status

RX

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Drug Status Breakdown
2 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

AMMONIA N 13

Application Number

210524

Product Number

1

Active Ingredient

AMMONIA N-13

Dosage Form

-

Strength

22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)

FDA Approved Drug Data

Approved drug product information

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