Medunik
FDA Approved Drugs

Medunik

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 5
  • Latest Approval Date Apr 27, 2023
  • Data Source FDA
  • First Approval Date May 26, 2022
Company Overview

Company

Medunik

Country

U.S.A

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Company Snapshot

Medunik

2 Research Way Suite 1B Princeton, NJ 08540

U.S.A

medunikusa.com/ View on Map
FDA Approved Drug Records ( 5 records )
2022
26 May
RX Application: 212390

Drug Name

NITISINONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2022-05-26

212390 / 1

Active Ingredient

NITISINONE

Application Number

212390

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2022-05-26

Regulatory Status

RX

2022
26 May
RX Application: 212390

Drug Name

NITISINONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-05-26

212390 / 2

Active Ingredient

NITISINONE

Application Number

212390

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2022-05-26

Regulatory Status

RX

2022
26 May
RX Application: 212390

Drug Name

NITISINONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-05-26

212390 / 3

Active Ingredient

NITISINONE

Application Number

212390

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2022-05-26

Regulatory Status

RX

2023
27 Apr
RX Application: 212390

Drug Name

NITISINONE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2023-04-27

212390 / 4

Active Ingredient

NITISINONE

Application Number

212390

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2023-04-27

Regulatory Status

RX

2022
17 Jun
RX Application: 216513

Drug Name

PHEBURANE

Product Number

1

Dosage Form

-

Strength

84GM/BOT

Approval Date

2022-06-17

216513 / 1

Active Ingredient

SODIUM PHENYLBUTYRATE

Application Number

216513

Product Number

1

Dosage Form

-

Strength

84GM/BOT

Approval Date

2022-06-17

Regulatory Status

RX

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Drug Status Breakdown
5 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

NITISINONE

Application Number

212390

Product Number

1

Active Ingredient

NITISINONE

Dosage Form

-

Strength

2MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

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Reliable Data

Organized FDA drug records

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