FDA APPLICATION 18082 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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1 CORPORATE CONTENT #SupplierSpotlight, 11 DATA COMPILATION #PharmaFlow, 2638 NEWS #PharmaBuzz

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2638 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

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

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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

830 FDF Dossiers
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 1SYRUP;ORAL

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01 1DISCN

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01 1DEPAKENE

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01 1Yes

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Brand Name : DEPAKENE

euroPLX 86 Munich

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RLD : Yes

TE Code :

VALPROIC ACID

Dosage Form : SYRUP; ORAL

Proprietary Name : DEPAKENE

Dosage Strength : 250MG/5ML **Federal Regi...

Approval Date : 1982-01-01

Application Number : 18082

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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