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Approved Drug Products containing Prestwick3_000651 listed in the FDA Orange Book. Original Data : FDA Website

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01 3SANOFI AVENTIS US

02 3ACCORD HLTHCARE

03 3ACTAVIS LABS FL INC

04 3AUROBINDO PHARMA LTD

05 3CARLSBAD

06 3CHARTWELL MOLECULAR

07 3DR REDDYS LABS LTD

08 3EPIC PHARMA LLC

09 3HIKMA PHARMS

10 3INDOCO REMEDIES

11 6MICRO LABS

12 3MYLAN

13 3NORVIUM BIOSCIENCE

14 4PRINSTON INC

15 2RANBAXY

16 4RANBAXY LABS LTD

17 2SANDOZ

18 5SB PHARMCO

19 2TAKEDA PHARMS USA

20 3TEVA

21 5TEVA PHARMS USA

22 3WATSON LABS

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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 : Yes

TE Code : AB

GLIMEPIRIDE

Brand Name : AMARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 1995-11-30

Application Number : 20496

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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 : Yes

TE Code : AB

GLIMEPIRIDE

Brand Name : AMARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date : 1995-11-30

Application Number : 20496

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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 : Yes

TE Code : AB

GLIMEPIRIDE

Brand Name : AMARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG

Approval Date : 1995-11-30

Application Number : 20496

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Sanofi Company Banner

04

SB PHARMCO

U.S.A
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SB PHARMCO

U.S.A
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GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Brand Name : AVANDARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-11-23

Application Number : 21700

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

SB PHARMCO

U.S.A
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Not Confirmed
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SB PHARMCO

U.S.A
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Not Confirmed

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Brand Name : AVANDARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-11-23

Application Number : 21700

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

SB PHARMCO

U.S.A
Formnext Forum
Not Confirmed
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SB PHARMCO

U.S.A
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Not Confirmed

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Brand Name : AVANDARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-11-23

Application Number : 21700

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

SB PHARMCO

U.S.A
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Not Confirmed
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SB PHARMCO

U.S.A
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Not Confirmed

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Brand Name : AVANDARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-03-30

Application Number : 21700

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

SB PHARMCO

U.S.A
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SB PHARMCO

U.S.A
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Not Confirmed

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Brand Name : AVANDARYL

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-03-30

Application Number : 21700

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

09

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Not Confirmed
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Not Confirmed

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Brand Name : DUETACT

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG;30MG

Approval Date : 2006-07-28

Application Number : 21925

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

Formnext Forum
Not Confirmed
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GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Brand Name : DUETACT

Dosage Form : TABLET;ORAL

Dosage Strength : 4MG;30MG

Approval Date : 2006-07-28

Application Number : 21925

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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