Elysium Pharmaceutical | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Elysium Pharmaceutical
FDA Orange Book

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Aspen API. More than just an API™

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jdmfs-not-supported-m-2025-04-28

Elysium Pharmaceutical

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 3 News #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

5 FDF Dossiers, 5 FDA Orange Book

5 FDF Dossiers
5 FDA Orange Book

INSPECTIONS & REGISTRATIONS

1 FDA

1 FDA

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FILTER :

filter Active Ingredients Reset all filters

5 All

01 1AMANTADINE HYDROCHLORIDE

02 1CYPROHEPTADINE HYDROCHLORIDE

03 1POLYETHYLENE GLYCOL 3350

04 2TOLTERODINE TARTRATE

filter Dosage Reset all filters

5 All

01 1FOR SOLUTION;ORAL

02 2SYRUP;ORAL

03 2TABLET;ORAL

filter Dosage Strength Reset all filters

5 All

01 117GM/SCOOPFUL

02 11MG

03 12MG

04 12MG/5ML

05 150MG/5ML

filter Regulatory Info Reset all filters

5 All

01 1OTC

02 4RX

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01

Brand Name : AMANTADINE HYDROCHLO...

BPI Europe

Not Confirmed

Brand Name : AMANTADINE HYDROCHLO...

BPI Europe

Not Confirmed

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RLD : No

TE Code : AA

AMANTADINE HYDROCHLORIDE

Elysium Pharmaceutical

Dosage Form : SYRUP; ORAL

Proprietary Name : AMANTADINE HYDROCHLORIDE

Dosage Strength : 50MG/5ML

Approval Date : 2021-08-20

Application Number : 214178

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
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02

Brand Name : CYPROHEPTADINE HYDRO...

BPI Europe

Not Confirmed

Brand Name : CYPROHEPTADINE HYDRO...

BPI Europe

Not Confirmed

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RLD : No

TE Code : AA

CYPROHEPTADINE HYDROCHLORIDE

Elysium Pharmaceutical

Dosage Form : SYRUP; ORAL

Proprietary Name : CYPROHEPTADINE HYDROCHLO...

Dosage Strength : 2MG/5ML

Approval Date : 2018-10-16

Application Number : 209108

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
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03

Brand Name : POLYETHYLENE GLYCOL ...

BPI Europe

Not Confirmed

Brand Name : POLYETHYLENE GLYCOL ...

BPI Europe

Not Confirmed

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RLD : No

TE Code :

POLYETHYLENE GLYCOL 3350

Elysium Pharmaceutical

Dosage Form : FOR SOLUTION; ORAL

Proprietary Name : POLYETHYLENE GLYCOL 3350

Dosage Strength : 17GM/SCOOPFUL

Approval Date : 2012-12-28

Application Number : 202071

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Product
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04

Brand Name : TOLTERODINE TARTRATE

BPI Europe

Not Confirmed

Brand Name : TOLTERODINE TARTRATE

BPI Europe

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

TOLTERODINE TARTRATE

Elysium Pharmaceutical

Dosage Form : TABLET; ORAL

Proprietary Name : TOLTERODINE TARTRATE

Dosage Strength : 1MG

Approval Date : 2019-12-30

Application Number : 210775

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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05

Brand Name : TOLTERODINE TARTRATE

BPI Europe

Not Confirmed

Brand Name : TOLTERODINE TARTRATE

BPI Europe

Not Confirmed

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.

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Digital Content

RLD : No

TE Code : AB

TOLTERODINE TARTRATE

Elysium Pharmaceutical

Dosage Form : TABLET; ORAL

Proprietary Name : TOLTERODINE TARTRATE

Dosage Strength : 2MG

Approval Date : 2019-12-30

Application Number : 210775

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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