FDA APPLICATION 21365 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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ACTIVE PHARMA INGREDIENTS

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

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7 USDMF
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7 KDMF
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DEVELOPMENTS

303 Drugs in Development

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FINISHED DOSAGE FORMULATIONS

830 FDF Dossiers, 285 FDA Orange Book, 148 Europe, 132 Canada, 202 Australia, 63 South Africa

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285 FDA Orange Book
148 Europe
132 Canada
202 Australia
63 South Africa

INSPECTIONS & REGISTRATIONS

96 FDA, 39 EDQM, 2 GDUFA

96 FDA
39 EDQM
2 GDUFA

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01 1ABBVIE

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01 1SOLUTION;ORAL

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01 1DISCN

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01 1LEXAPRO

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01 1Yes

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Brand Name : LEXAPRO

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RLD : Yes

TE Code :

ESCITALOPRAM OXALATE

Dosage Form : SOLUTION; ORAL

Proprietary Name : LEXAPRO

Dosage Strength : EQ 5MG BASE/5ML **Federa...

Approval Date : 2002-11-27

Application Number : 21365

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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