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

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01 1AUROBINDO PHARMA

02 1DR REDDYS LABS LTD

03 1HALEON US HOLDINGS

04 1PERRIGO R AND D

05 1PLD ACQUISITIONS LLC

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01

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DIPHENHYDRAMINE CITRATE; IBUPROFEN

Brand Name : IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 38MG;200MG

Approval Date : 2022-05-31

Application Number : 216204

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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02

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DIPHENHYDRAMINE CITRATE; IBUPROFEN

Brand Name : ADVIL PM

Dosage Form : TABLET;ORAL

Dosage Strength : 38MG;200MG

Approval Date : 2005-12-21

Application Number : 21394

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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03

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DIPHENHYDRAMINE CITRATE; IBUPROFEN

Brand Name : IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 38MG;200MG

Approval Date : 2008-12-22

Application Number : 79113

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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04

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DIPHENHYDRAMINE CITRATE; IBUPROFEN

Brand Name : IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 38MG;200MG

Approval Date : 2024-04-11

Application Number : 211404

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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05

DR REDDYS LABS LTD

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DR REDDYS LABS LTD

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Luxepack
Not Confirmed

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Brand Name : IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : 38MG;200MG

Approval Date : 2009-07-08

Application Number : 90619

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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