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

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BioProcess International

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : BIAXIN

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-10-31

Application Number : 50662

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

02

DR REDDYS LABS SA

India

CPhI Worldwide, Milan

Booth #24A41

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

India

RLD : No

TE Code : AB

Brand Name : CLARITHROMYCIN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2005-05-18

Application Number : 65154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

03

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

India

RLD : No

TE Code : AB

Brand Name : CLARITHROMYCIN

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2013-06-10

Application Number : 202710

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

04

ABBVIE

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BioProcess International

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : BIAXIN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-10-31

Application Number : 50662

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

05

ABBVIE INC

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BioProcess International

Not Confirmed

U.S.A

RLD :

TE Code :

Brand Name : BIAXIN XL

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date :

Application Number : 50697

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Corporate PDF

06

ABBVIE INC

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BioProcess International

Not Confirmed

U.S.A

RLD :

TE Code :

Brand Name : BIAXIN XL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date :

Application Number : 50697

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Corporate PDF

07

ABBVIE

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BioProcess International

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : BIAXIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 125MG/5ML

Approval Date : 1993-12-23

Application Number : 50698

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

08

ABBVIE

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BioProcess International

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : BIAXIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 250MG/5ML

Approval Date : 1993-12-23

Application Number : 50698

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

09

ABBVIE

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BioProcess International

Not Confirmed

U.S.A

RLD : No

TE Code :

Brand Name : BIAXIN

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 187MG/5ML

Approval Date : 1998-09-30

Application Number : 50698

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Corporate PDF

10

ABBVIE

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

BioProcess International

Not Confirmed

U.S.A

RLD : Yes

TE Code :