FDA APPLICATION 21883 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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AbbVie Inc

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EVENTS

Webinars & Exhibitions

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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01 1ABBVIE

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01 1POWDER;INTRAVENOUS

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01 1RX

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01 1DALVANCE

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01 1Yes

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Brand Name : DALVANCE

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RLD : Yes

TE Code :

DALBAVANCIN HYDROCHLORIDE

Dosage Form : POWDER; INTRAVENOUS

Proprietary Name : DALVANCE

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2014-05-23

Application Number : 21883

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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