FDA APPLICATION 206619 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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AbbVie Inc

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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
6 CEP/COS
7 KDMF
7 NDC API
8 Listed APIs

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306 Drugs in Development

306 Drugs in Development

FINISHED DOSAGE FORMULATIONS

832 FDF Dossiers, 287 FDA Orange Book, 148 Europe, 132 Canada, 202 Australia, 63 South Africa

832 FDF Dossiers
287 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 1TABLET;ORAL

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01 1DISCN

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01 1VIEKIRA PAK (COPACKAGED)

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01 1Yes

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Brand Name : VIEKIRA PAK (COPACKA...

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RLD : Yes

TE Code :

DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR

Dosage Form : TABLET; ORAL

Proprietary Name : VIEKIRA PAK (COPACKAGED)

Dosage Strength : EQ 250MG BASE;12.5MG, 75...

Approval Date : 2014-12-19

Application Number : 206619

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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