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Approved Drug Products containing Prestwick3_000358 listed in the FDA Orange Book. Original Data : FDA Website

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01 6ALKEM LABS LTD

02 2ANDA REPOSITORY

03 8APOTHECON

04 3AUROBINDO PHARMA

05 6BARR

06 2BELCHER PHARMS

07 4CHARTWELL RX

08 5FACTA FARMA

09 2HIKMA

10 2HIKMA PHARMS

11 2IVAX SUB TEVA PHARMS

12 5LILLY

13 4LUPIN

14 7PRAGMA

15 2PUREPAC PHARM

16 2RANBAXY LABS LTD

17 2STEVENS J

18 2SUN PHARM INDS (IN)

19 4SUN PHARM INDS LTD

20 14TEVA

21 5VITARINE

22 2YOSHITOMI

23 2YUNG SHIN PHARM

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLET

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 1982-01-01

Application Number : 50440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLET

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1GM BASE

Approval Date : 1982-01-01

Application Number : 50440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLET

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE

Approval Date : 1987-02-26

Application Number : 50440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 50405

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 50405

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-05-12

Application Number : 50405

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-05-12

Application Number : 50405

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 50406

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*

Approval Date : 1982-01-01

Application Number : 50406

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

CEPHALEXIN

Brand Name : KEFLEX

Dosage Form : FOR SUSPENSION;ORAL

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

Approval Date : 1982-01-01

Application Number : 50406

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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