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Approved Drug Products containing Prestwick3_000105 listed in the FDA Orange Book. Original Data : FDA Website

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01 3SANOFI AVENTIS US

02 1AM THERAP

03 3BARR

04 2LANNETT

05 3LANNETT CO INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DANAZOL

Brand Name : DANOCRINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17557

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DANAZOL

Brand Name : DANOCRINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17557

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DANAZOL

Brand Name : DANOCRINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17557

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

04

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 1987-12-30

Application Number : 71569

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 1996-08-09

Application Number : 74582

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1998-05-29

Application Number : 74582

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Approval Date : 1998-05-29

Application Number : 74582

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2005-09-28

Application Number : 77246

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Approval Date : 2007-04-19

Application Number : 77246

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

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DANAZOL

Brand Name : DANAZOL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2007-04-19

Application Number : 77246

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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