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Approved Drug Products of Dexcel Pharma listed in the FDA Orange Book. Original Data : FDA Website

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01 1CHLORHEXIDINE GLUCONATE

02 1DEXAMETHASONE

03 1DICLOFENAC SODIUM

04 1DONEPEZIL HYDROCHLORIDE

05 1ESOMEPRAZOLE MAGNESIUM

06 3ISOSORBIDE MONONITRATE

07 1LANSOPRAZOLE

08 2LEVETIRACETAM

09 2OMEPRAZOLE

10 1PANTOPRAZOLE SODIUM

11 3VENLAFAXINE HYDROCHLORIDE

12 2VIGABATRIN

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01

Brand Name : PERIOCHIP

BioProcess International
Not Confirmed
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Brand Name : PERIOCHIP

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET; DENTAL

Proprietary Name : PERIOCHIP

Dosage Strength : 2.5MG

Approval Date : 1998-05-15

Application Number : 20774

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

Brand Name : HEMADY

BioProcess International
Not Confirmed
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Brand Name : HEMADY

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET; ORAL

Proprietary Name : HEMADY

Dosage Strength : 20MG

Approval Date : 2019-10-03

Application Number : 211379

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Brand Name : DICLOFENAC SODIUM

BioProcess International
Not Confirmed
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Brand Name : DICLOFENAC SODIUM

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : DICLOFENAC SODIUM

Dosage Strength : 100MG

Approval Date : 2002-11-06

Application Number : 76201

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

Brand Name : DONEPEZIL HYDROCHLOR...

BioProcess International
Not Confirmed
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Brand Name : DONEPEZIL HYDROCHLOR...

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET; ORAL

Proprietary Name : DONEPEZIL HYDROCHLORIDE

Dosage Strength : 23MG

Approval Date : 2016-02-19

Application Number : 203713

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Brand Name : ESOMEPRAZOLE MAGNESI...

BioProcess International
Not Confirmed
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Brand Name : ESOMEPRAZOLE MAGNESI...

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, ORALLY DISINTEGRATING,...

Proprietary Name : ESOMEPRAZOLE MAGNESIUM

Dosage Strength : EQ 20MG BASE

Approval Date : 2020-10-20

Application Number : 214278

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ISOSORBIDE MONONITRATE

Dosage Strength : 60MG

Approval Date : 2000-04-17

Application Number : 75522

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ISOSORBIDE MONONITRATE

Dosage Strength : 30MG

Approval Date : 2016-09-20

Application Number : 75522

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ISOSORBIDE MONONITRATE

Dosage Strength : 120MG

Approval Date : 2018-08-29

Application Number : 210822

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

Brand Name : LANSOPRAZOLE

BioProcess International
Not Confirmed
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Brand Name : LANSOPRAZOLE

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, ORALLY DISINTEGRATING,...

Proprietary Name : LANSOPRAZOLE

Dosage Strength : 15MG

Approval Date : 2016-06-07

Application Number : 208025

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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10

Brand Name : LEVETIRACETAM

BioProcess International
Not Confirmed
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Brand Name : LEVETIRACETAM

BioProcess International
Not Confirmed
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Dexcel Pharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : LEVETIRACETAM

Dosage Strength : 500MG

Approval Date : 2015-09-04

Application Number : 202167

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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