FDA APPLICATION 20675 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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EVENTS

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Webinars & Exhibitions

PRESENTATION(s)

Product List 2025

Product List 2025

DIGITAL CONTENT

1 Corporate Content #SupplierSpotlight, 14 Data Compilation #PharmaFlow, 2773 News #PharmaBuzz

1 Corporate Content #SupplierSpotlight
14 Data Compilation #PharmaFlow
2773 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

25 All APIs, 7 USDMF, 6 CEP/COS, 7 KDMF, 7 NDC API, 8 Listed APIs

25 All APIs
7 USDMF
6 CEP/COS
7 KDMF
7 NDC API
8 Listed APIs

DEVELOPMENTS

1299 Drugs in Development

1299 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1001 FDF Dossiers, 297 FDA Orange Book, 277 Europe, 130 Canada, 233 Australia, 64 South Africa

1001 FDF Dossiers
297 FDA Orange Book
277 Europe
130 Canada
233 Australia
64 South Africa

INSPECTIONS & REGISTRATIONS

94 FDA, 45 EDQM, 2 GDUFA

94 FDA
45 EDQM
2 GDUFA

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filter Applicant Reset all filters

2 All

01 2ABBVIE

filter Dosage Reset all filters

2 All

01 2TABLET;ORAL

filter Regulatory Info Reset all filters

2 All

01 2DISCN

filter Brand Name Reset all filters

2 All

01 1URSO 250

02 1URSO FORTE

filter RLD Reset all filters

2 All

01 2Yes

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01

Brand Name : URSO 250

Bio-Europe Autumn

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RLD : Yes

TE Code :

Dosage Form : TABLET; ORAL

Proprietary Name : URSO 250

Dosage Strength : 250MG

Approval Date : 1997-12-10

Application Number : 20675

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : URSO FORTE

Bio-Europe Autumn

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RLD : Yes

TE Code :

Dosage Form : TABLET; ORAL

Proprietary Name : URSO FORTE

Dosage Strength : 500MG

Approval Date : 2004-07-21

Application Number : 20675

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

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