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Approved Drug Products containing 203088 listed in the FDA Orange Book. Original Data : FDA Website

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01

Brand Name : DULOXETINE HYDROCHLO...

Breckenridge Pharmaceutical

Dosage Form : CAPSULE, DELAYED REL PELLETS; ...

Proprietary Name : DULOXETINE HYDROCHLORIDE

Dosage Strength : EQ 20MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

02

Brand Name : DULOXETINE HYDROCHLO...

Breckenridge Pharmaceutical

Dosage Form : CAPSULE, DELAYED REL PELLETS; ...

Proprietary Name : DULOXETINE HYDROCHLORIDE

Dosage Strength : EQ 40MG BASE

Approval Date : 2018-05-18

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

03

Brand Name : DULOXETINE HYDROCHLO...

Breckenridge Pharmaceutical

Dosage Form : CAPSULE, DELAYED REL PELLETS; ...

Proprietary Name : DULOXETINE HYDROCHLORIDE

Dosage Strength : EQ 30MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

04

Brand Name : DULOXETINE HYDROCHLO...

Breckenridge Pharmaceutical

Dosage Form : CAPSULE, DELAYED REL PELLETS; ...

Proprietary Name : DULOXETINE HYDROCHLORIDE

Dosage Strength : EQ 60MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical